Elizabeth Dougherty,
Harvard-MIT Division of Health Sciences and TechnologyFebruary 18, 2008
MIT researchers and colleagues have created a waterproof adhesive bandage inspired by gecko lizards that may soon join sutures and staples as a basic operating room tool for patching up surgical wounds or internal injuries.
Drawing on some of the principles that make gecko feet unique, the surface of the bandage has the same kind of nanoscale hills and valleys that allow the lizards to cling to walls and ceilings. Layered over this landscape is a thin coating of glue that helps the bandage stick in wet environments, such as to heart, bladder or lung tissue. And because the bandage is biodegradable, it dissolves over time and does not have to be removed.
The team is led by MIT Institute Professor Robert Langer and Jeff Karp, an instructor of medicine at Brigham and Women's Hospital and Harvard Medical School. Both are also faculty members at the Harvard-MIT Division of Health Sciences and Technology (HST).
The work is described in the Feb. 11 online issue of the Proceedings of the National Academy of Sciences.
"There is a big need for a tape-based medical adhesive," said Karp. For instance, a surgical adhesive tape made from this new material could wrap around and reseal the intestine after the removal of a diseased segment or after a gastric bypass procedure. It could also patch a hole caused by an ulcer. Because it can be folded and unfolded, it has a potential application in minimally invasive surgical procedures that are particularly difficult to suture because they are performed through a very small incision.
Gecko-like dry adhesives have been around since about 2001 but there have been significant challenges to adapt this technology for medical applications given the strict design criteria required. For use in the body, they must be adapted to stick in a wet environment and be constructed from materials customized for medical applications. Such materials must be biocompatible, meaning they do not cause inflammation; biodegradable, meaning they dissolve over time without producing toxins; and elastic, so that they can conform to and stretch with the body's tissues.
The MIT researchers met these requirements by building their medical adhesive with a "biorubber" invented by Karp, Langer and others. Using micropatterning technology--the same technology used to create computer chips--the researchers shaped the biorubber into different hill and valley profiles at nanoscale dimensions. After testing them on intestinal tissue taken from pigs, they selected the stickiest profile, one with pillars spaced just wide enough to grip and interlock with the underlying tissue.
Karp then added a very thin layer of a sugar-based glue, to create a strong bond even to a wet surface. The resulting bandage "is something we never expect to remove," said Karp. Because of that difference, he continued, "we're not mimicking the gecko"--which has sticky feet but can still lift them up to walk--"we are inspired by the gecko to create a patterned interface to enhance the surface area of contact and thus the overall strength of adhesion."
When tested against the intestinal tissue samples from pigs, the nanopatterned adhesive bonds were twice as strong as unpatterned adhesives. In tests of the new adhesive in living rats, the glue-coated nanopatterned adhesive showed over a 100 percent increase in adhesive strength compared to the same material without the glue. Moreover, the rats showed only a mild inflammatory response to the adhesive, a minor reaction that does not need to be overcome for clinical use.
Among other advantages, the adhesive could be infused with drugs designed to release as the biorubber degrades. Further, the elasticity and degradation rate of the biorubber are tunable, as is the pillared landscape. This means that the new adhesives can be customized to have the right elasticity, resilience and grip for different medical applications.
"This is an exciting example of how nanostructures can be controlled, and in so doing, used to create a new family of adhesives," said Langer.
Other MIT authors of the paper are co-first authors Alborz Mahdavi, a former MIT lab technician now at the California Institute of Technology; Lino Ferreira, a former MIT postdoctoral fellow now at the University of Coimbra, Portugal; Jason W. Nichol and Edwin P. Chan, HST postdoctoral fellows; David J.D. Carter and Jeff Borenstein of Draper Laboratory; HST doctoral student Chris Bettinger; and MIT graduate students Siamrut Patanavanich, Loice Chignozha, Eli B. Joseph, Alex Galakatos and Seungpyo Hong, all from the Department of Chemical Engineering. Additional authors are from Massachusetts General Hospital and the University of Basel, Switzerland.
The work was funded by the National Institutes of Health, the Materials Research Science and Engineering Center (MRSEC) program of the National Science Foundation, and the MIT-Portugal program.
http://web.mit.edu/newsoffice/2008/adhesive-0218.html
Monday, February 25, 2008
Rogue doctor removes woman's ovaries without her knowledge
A Wanganui woman had her ovaries removed without her knowledge by a rogue doctor.
Her case, and the doctor, has been investigated as part of a Health and Disability Commissioner report to be made public on Tuesday. The Wanganui District Health Board (DHB) is expected to be severely criticised.
Fredericka Himmel is terrified of ever going under the knife again. The Wanganui grandmother is still haunted by the work of Dr Roman Hasil.
She says Hasil diagnosed massive adhesions on her ovaries. After he resigned from Wanganui Hospital, his notes were later used by other surgeons and the ovaries were removed. But, examined later, they showed no sign of any other problems.
The gynaecologist - now Australian based - is at the centre of a Health and Disability Commissioner's report to be released publicly on Tuesday..
It is expected to target weaknesses in the Wanganui DHB's hiring process, Hasil's supervision and the way complaints were handled.
Himmel is not the only Wanganui patient to have her ovaries removed unnecessarily.
John Rowan QC confirmed to 3 News a young woman had hers removed by Dr Hasil. But it was not discussed before surgery and Hasil never told her after she woke. She found out months later.
Rowan is organising legal action against the Wanganui DHB over the incident.
Rowan told 3 News he believes more women will come forward after the report is released. Just what legal action will be taken will not be decided until he has read the findings. But he hopes the board will respond in a sensible way.
The DHB will not talk public until the report is released.
Click here for video
Her case, and the doctor, has been investigated as part of a Health and Disability Commissioner report to be made public on Tuesday. The Wanganui District Health Board (DHB) is expected to be severely criticised.
Fredericka Himmel is terrified of ever going under the knife again. The Wanganui grandmother is still haunted by the work of Dr Roman Hasil.
She says Hasil diagnosed massive adhesions on her ovaries. After he resigned from Wanganui Hospital, his notes were later used by other surgeons and the ovaries were removed. But, examined later, they showed no sign of any other problems.
The gynaecologist - now Australian based - is at the centre of a Health and Disability Commissioner's report to be released publicly on Tuesday..
It is expected to target weaknesses in the Wanganui DHB's hiring process, Hasil's supervision and the way complaints were handled.
Himmel is not the only Wanganui patient to have her ovaries removed unnecessarily.
John Rowan QC confirmed to 3 News a young woman had hers removed by Dr Hasil. But it was not discussed before surgery and Hasil never told her after she woke. She found out months later.
Rowan is organising legal action against the Wanganui DHB over the incident.
Rowan told 3 News he believes more women will come forward after the report is released. Just what legal action will be taken will not be decided until he has read the findings. But he hopes the board will respond in a sensible way.
The DHB will not talk public until the report is released.
Click here for video
Wednesday, February 13, 2008
METHYLENE BLUE
http://www.drugs.com/cons/methylene-blue.html
METHYLENE BLUE (Systemic)
display_ad(3);
Some commonly used brand names are:
In the U.S.—
Urolene Blue
Generic name product may be available in the U.S. and Canada.
Other commonly used names are aniline violet , methylthionine chloride , and tetramethylthionine chloride .
Category
Antimethemoglobinemic
Diagnostic aid, tissue dye
Description
Methylene (METH-i-leen) blue is used to treat a condition called methemoglobinemia. This condition occurs when the blood cannot deliver oxygen where it is needed in the body. Methylene blue is also used as a dye to stain certain parts of the body before or during surgery.
Oral
Tablets (U.S.)
Parenteral
Injection (U.S. and Canada)
Before Using This Medicine
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For methylene blue, the following should be considered:
Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to methylene blue. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.
Pregnancy—Studies on effects in pregnancy have not been done in either humans or animals.
Breast-feeding—It is not known whether methylene blue passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.
Children—Babies are especially sensitive to the effects of methylene blue. This may increase the chance of side effects during treatment.
Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing the use of methylene blue in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.
Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other medical problems—The presence of other medical problems may affect the use of methylene blue. Make sure you tell your doctor if you have any other medical problems, especially:
Glucose-6-phosphate dehydrogenase (G6PD) deficiency—Methylene blue may cause anemia or make methemoglobinemia worse
Kidney disease—In patients with kidney disease methylene blue may accumulate in the body; smaller doses of this medicine may be needed
Methemoglobinemia to treat cyanide toxicity—Methylene blue may make cyanide toxicity worse by increasing the amount of cyanide in the blood
Proper Use of This Medicine
For patients taking the tablet form of this medicine:
Take tablets after meals with a full glass (8 ounces) of water.
Take this medicine only as directed . Do not take more of it and do not take it more often than recommended on the label unless directed by your doctor. To do so may increase the chance of side effects.
Dosing—The dose of methylene blue will be different for different patients. Follow your doctor's orders or the directions on the label . The following information includes only the average doses of methylene blue. If your dose is different, do not change it unless your doctor tells you to do so.
For oral dosage form (tablets):
For methemoglobinemia:
Adults and children—100 to 300 milligrams (mg) a day.
For injection dosage form:
For methemoglobinemia:
Adults and children—Dose is based on body weight or size and must be determined by your doctor. The dose is usually 1 to 2 mg per kilogram (kg) (0.45 to 0.9 mg per pound) of body weight, or 25 to 50 mg per square meter of body surface area, injected into a vein over a period of five minutes. A second dose may be given after one hour, if needed.
Missed dose—If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage—To store this medicine:
Keep out of the reach of children.
Store away from heat and direct light.
Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
Keep the medicine from freezing. Do not refrigerate.
Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.
Precautions While Using This Medicine
Before you have any medical tests, tell the doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.
Side Effects of This Medicine
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Symptoms of overdose
Anxiety; back pain; bluish fingernails, lips, or skin; chest pain; chills; confusion; difficulty in breathing; dizziness; headache; leg pain; nausea and vomiting; severe sweating; stomach pain; trembling; unusual tiredness or weakness
Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:
More common
Greenish blue to blue discoloration of urine and stools
Less common
Diarrhea; nausea and vomiting; painful urination or increased need to urinate (with tablet form)
Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.
Developed: 05/27/1994
The information contained in the Thomson Healthcare (Micromedex) products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.
The use of the Thomson Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Healthcare does not assume any responsibility or risk for your use of the Thomson Healthcare products.
_______________________________________
http://www.rxlist.com/cgi/generic/methyleneblue_cp.htm
Methylene Blue
Methylene Blue is Phenothiazin-5-ium, 3,7-bis (dimethylamino)-,chloride, trihydrate. It will produce two opposite actions on hemoglobin. Low concentrations will convert methemoglobin to hemoglobin. High concentrations convert the ferrous iron of reduced hemoglobin to ferric iron which results in the formation of methemoglobin.
Methylene Blue must be injected intravenously very slowly over a period of several minutes to prevent local high concentration of the compound from producing additional methemoglobin.
Do not exceed recommended dosage.
_____________________________________
Both of these links contain extensive information on the substance in question with SprayGel Adhesion Barrier.
METHYLENE BLUE (Systemic)
display_ad(3);
Some commonly used brand names are:
In the U.S.—
Urolene Blue
Generic name product may be available in the U.S. and Canada.
Other commonly used names are aniline violet , methylthionine chloride , and tetramethylthionine chloride .
Category
Antimethemoglobinemic
Diagnostic aid, tissue dye
Description
Methylene (METH-i-leen) blue is used to treat a condition called methemoglobinemia. This condition occurs when the blood cannot deliver oxygen where it is needed in the body. Methylene blue is also used as a dye to stain certain parts of the body before or during surgery.
Oral
Tablets (U.S.)
Parenteral
Injection (U.S. and Canada)
Before Using This Medicine
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For methylene blue, the following should be considered:
Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to methylene blue. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.
Pregnancy—Studies on effects in pregnancy have not been done in either humans or animals.
Breast-feeding—It is not known whether methylene blue passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.
Children—Babies are especially sensitive to the effects of methylene blue. This may increase the chance of side effects during treatment.
Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing the use of methylene blue in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.
Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other medical problems—The presence of other medical problems may affect the use of methylene blue. Make sure you tell your doctor if you have any other medical problems, especially:
Glucose-6-phosphate dehydrogenase (G6PD) deficiency—Methylene blue may cause anemia or make methemoglobinemia worse
Kidney disease—In patients with kidney disease methylene blue may accumulate in the body; smaller doses of this medicine may be needed
Methemoglobinemia to treat cyanide toxicity—Methylene blue may make cyanide toxicity worse by increasing the amount of cyanide in the blood
Proper Use of This Medicine
For patients taking the tablet form of this medicine:
Take tablets after meals with a full glass (8 ounces) of water.
Take this medicine only as directed . Do not take more of it and do not take it more often than recommended on the label unless directed by your doctor. To do so may increase the chance of side effects.
Dosing—The dose of methylene blue will be different for different patients. Follow your doctor's orders or the directions on the label . The following information includes only the average doses of methylene blue. If your dose is different, do not change it unless your doctor tells you to do so.
For oral dosage form (tablets):
For methemoglobinemia:
Adults and children—100 to 300 milligrams (mg) a day.
For injection dosage form:
For methemoglobinemia:
Adults and children—Dose is based on body weight or size and must be determined by your doctor. The dose is usually 1 to 2 mg per kilogram (kg) (0.45 to 0.9 mg per pound) of body weight, or 25 to 50 mg per square meter of body surface area, injected into a vein over a period of five minutes. A second dose may be given after one hour, if needed.
Missed dose—If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage—To store this medicine:
Keep out of the reach of children.
Store away from heat and direct light.
Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
Keep the medicine from freezing. Do not refrigerate.
Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.
Precautions While Using This Medicine
Before you have any medical tests, tell the doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.
Side Effects of This Medicine
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Symptoms of overdose
Anxiety; back pain; bluish fingernails, lips, or skin; chest pain; chills; confusion; difficulty in breathing; dizziness; headache; leg pain; nausea and vomiting; severe sweating; stomach pain; trembling; unusual tiredness or weakness
Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:
More common
Greenish blue to blue discoloration of urine and stools
Less common
Diarrhea; nausea and vomiting; painful urination or increased need to urinate (with tablet form)
Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.
Developed: 05/27/1994
The information contained in the Thomson Healthcare (Micromedex) products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.
The use of the Thomson Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Healthcare does not assume any responsibility or risk for your use of the Thomson Healthcare products.
_______________________________________
http://www.rxlist.com/cgi/generic/methyleneblue_cp.htm
Methylene Blue
Methylene Blue is Phenothiazin-5-ium, 3,7-bis (dimethylamino)-,chloride, trihydrate. It will produce two opposite actions on hemoglobin. Low concentrations will convert methemoglobin to hemoglobin. High concentrations convert the ferrous iron of reduced hemoglobin to ferric iron which results in the formation of methemoglobin.
Methylene Blue must be injected intravenously very slowly over a period of several minutes to prevent local high concentration of the compound from producing additional methemoglobin.
Do not exceed recommended dosage.
_____________________________________
Both of these links contain extensive information on the substance in question with SprayGel Adhesion Barrier.
Tuesday, February 12, 2008
Scarring gel in spotlight
By JANINE RANKIN - Manawatu Standard
Tuesday, 12 February 2008
The one in five Palmerston North women and girls who suffer from endometriosis need not be alarmed at reports that a product used in surgical treatment could make their condition worse.
The surgical spray gel at the centre of a Wellington gynaecologist's concerns that it causes internal scarring isn't widely used in Palmerston North.
MidCentral Health and private specialist Digby Ngan Kee says he doesn't use the product and isn't aware of any other surgeons locally who use it.
"It is a very expensive product, and there is no good evidence that it is effective," he said.
Wellington gynaecologist Hanifa Koya says she's stopped using the gel since she's had endometriosis patients returning for repeat surgery after its use, to repair the sort of scarring the product was supposed to prevent.
Endometriosis New Zealand chief executive Deborah Bush, who originally set up the national support group in Palmerston North, said she didn't believe women should be alarmed.
The evidence that the gel actually caused scarring over and above the damage done by endometriosis was anecdotal rather than scientific, she said.
"It's a horrible disease, and we don't know what causes it. Surgeons can excise the disease, but that doesn't mean a woman won't develop more adhesions."
In women with endometriosis the tissue that developed in the uterus each month also formed in other parts of the abdomen causing pain, scarring, and often damaging fertility.
Ms Bush said although some surgeons were reporting an increased rate of women coming back for repeat surgery, there was no good evidence the scarring was a result of the gel rather than a result of surgery or the disease.
Dr Ngan Kee said the numbers of women returning for surgery were still too small to give an accurate view. Women struggling with endometriosis will be able to attend a seminar at Palmerston North Hospital next month when Ms Bush, a gynaecologist, and an authority on nutrition and fertility will talk about latest treatments and self-help options
Tuesday, 12 February 2008
The one in five Palmerston North women and girls who suffer from endometriosis need not be alarmed at reports that a product used in surgical treatment could make their condition worse.
The surgical spray gel at the centre of a Wellington gynaecologist's concerns that it causes internal scarring isn't widely used in Palmerston North.
MidCentral Health and private specialist Digby Ngan Kee says he doesn't use the product and isn't aware of any other surgeons locally who use it.
"It is a very expensive product, and there is no good evidence that it is effective," he said.
Wellington gynaecologist Hanifa Koya says she's stopped using the gel since she's had endometriosis patients returning for repeat surgery after its use, to repair the sort of scarring the product was supposed to prevent.
Endometriosis New Zealand chief executive Deborah Bush, who originally set up the national support group in Palmerston North, said she didn't believe women should be alarmed.
The evidence that the gel actually caused scarring over and above the damage done by endometriosis was anecdotal rather than scientific, she said.
"It's a horrible disease, and we don't know what causes it. Surgeons can excise the disease, but that doesn't mean a woman won't develop more adhesions."
In women with endometriosis the tissue that developed in the uterus each month also formed in other parts of the abdomen causing pain, scarring, and often damaging fertility.
Ms Bush said although some surgeons were reporting an increased rate of women coming back for repeat surgery, there was no good evidence the scarring was a result of the gel rather than a result of surgery or the disease.
Dr Ngan Kee said the numbers of women returning for surgery were still too small to give an accurate view. Women struggling with endometriosis will be able to attend a seminar at Palmerston North Hospital next month when Ms Bush, a gynaecologist, and an authority on nutrition and fertility will talk about latest treatments and self-help options
New Wound Closures Get Seal of Approval
New Wound Closures Get Seal of Approval
By P. Driscoll
From January 2008 issue of MedMarkets, with excerpts from “Worldwide Wound Management, 2007-2016,” report #S145.
The market for surgical sealants is expected to grow in double digits over the next five years as aging populations drive increases in caseloads (see chart below). In addition, less morbidity and better outcomes are seen with the latest fibrin sealants, high-strength glues and adhesion prevention products, thus spurring increased adoption of these technologies over traditional wound closure methods.
There are several main categories of closure and securement devices in use in the OR: sutures and staples, tapes, hemostats, fibrin glues and sealants, adhesion prevention products, and soft tissue attachment products.
Some leading companies in the modern wound closure market established their leadership positions when the market consisted exclusively of sutures, staples and tapes; others are new entrants based on expertise in areas such as adhesives. While the fibrin sealant market segment is dominated by Baxter Healthcare and CSL Behring, the high-strength glue segment is led by U.S. Surgical (now part of Covidien), Ethicon, and Aesculap (a B. Braun company). Key players in the market for adhesion prevention products are Ethicon, U.S. Surgical and Genzyme. Market shares for these companies are shown in the charts, “Leading Companies in the Sealants Market by Market Share.”
Leading Companies in Sealants Market by Market Share
By P. Driscoll
From January 2008 issue of MedMarkets, with excerpts from “Worldwide Wound Management, 2007-2016,” report #S145.
The market for surgical sealants is expected to grow in double digits over the next five years as aging populations drive increases in caseloads (see chart below). In addition, less morbidity and better outcomes are seen with the latest fibrin sealants, high-strength glues and adhesion prevention products, thus spurring increased adoption of these technologies over traditional wound closure methods.
There are several main categories of closure and securement devices in use in the OR: sutures and staples, tapes, hemostats, fibrin glues and sealants, adhesion prevention products, and soft tissue attachment products.
Some leading companies in the modern wound closure market established their leadership positions when the market consisted exclusively of sutures, staples and tapes; others are new entrants based on expertise in areas such as adhesives. While the fibrin sealant market segment is dominated by Baxter Healthcare and CSL Behring, the high-strength glue segment is led by U.S. Surgical (now part of Covidien), Ethicon, and Aesculap (a B. Braun company). Key players in the market for adhesion prevention products are Ethicon, U.S. Surgical and Genzyme. Market shares for these companies are shown in the charts, “Leading Companies in the Sealants Market by Market Share.”
Leading Companies in Sealants Market by Market Share
Source: MedMarket Diligence, LLC
Fibrin—The Body’s Sealant
Fibrin sealants are the most useful surgical hemostats because they can be used to clot blood but are also valuable for sealing around suture lines for organ transplants, mastectomies, and various resection procedures, as well as to prevent leakage of fluids and gases. A number of companies, including Harvest Technologies, Plasmaseal, ThermoGenesis, and Interpore Cross Medical, have developed active mixes of growth factors to aid repair and devices capable of preparing autologous fibrin and platelet formulations that can be used as sealants.
In July 2007, ThermoGenesis announced that the FDA had approved the CryoSeal FS system, the company’s autologous fibrin sealant, as an adjunct to hemostasis in liver resection surgery. The product was already cleared for sale throughout the European Community (CE Mark) for any type of surgery. The CryoSeal FS system, an automated device with a companion sterile blood processing disposable, is used to prepare fibrin sealants from plasma in about an hour. The system produces a surgical sealant by harvesting, from a patient’s plasma, wound healing proteins including fibrinogen and Factor VIII, and the activating enzyme thrombin. When combined at the bleeding wound site, the two components form an adhesive gel that helps stop bleeding and bonds tissue.
Thrombin is a predecessor of fibrin in the clotting cascade and is involved in converting (soluble) fibrinogen to (insoluble) fibrin. It is used in combination with fibrin for accelerated hemostasis.
On January 10, 2008, Omrix Biopharmaceuticals announced that the FDA had granted an expanded indication for general hemostasis in surgery for Evicel liquid fibrin sealant (human). Evicel is the first liquid fibrin sealant to be indicated as an adjunct to hemostasis for use in patients undergoing surgery when control of bleeding by standard surgical techniques is ineffective or impractical. Ethicon is Omrix’s marketing partner and will actively promote Evicel for a wide range of surgeries.
High-Strength Medical Adhesives
Fibrin-based wound closure products achieve hemostasis and have moderate adhesive properties that can help sutures to keep wound edges in apposition. Where greater adhesive strength is required, cyanoacrylate products are the main form of high-strength surgical glue approved for human clinical use. They are replacing sutures in many procedures but do not represent the ideal alternative to suturing, an ideal technology that is still sought by researchers. Cyanoacrylate glues used for external skin closure are approximately five times less strong than sutures, and cyanoacrylates produce cytotoxic compounds as part of the curing process when used for securing torn or excised tissue. This has delayed the development and clinical evaluation of potentially useful materials for internal surgical procedures. Nonetheless, cyanoacrylate glues are marketed actively by a number of companies for topical wound closure in accident/emergency situations and in surgical closure.
Leading products in this category include Dermabond, which is developed by Closure Medical and marketed by Ethicon. Dermabond is marketed in about 40 countries under EU- and FDA-approval for topical wound closure. For Ethicon, Dermabond represents the culmination of a five-year joint development program with Closure Medical that started in 1996.
Closure Medical, which is now incorporated into Ethicon, also developed Omnex vascular sealant, a high-strength adhesive that received the CE mark in 2005.
Post-Surgical Adhesion Prevention
Post-operative adhesions tend to arise when internal connective tissues are exposed to air and instrumentation during the surgical procedure and any irritation caused to internal organs. Abdominal surgery often leads to some form of adhesion formation, as does cardiovascular surgery. There are roughly 8 million–9 million abdominal surgeries, more than 2 million gynecologic surgeries, and 9 million cardiovascular surgeries every year, with about 1.7 million procedures associated with some risk of critical adhesion formation. Thus there is enough risk for adhesions from these procedures to encourage the use of adhesion prevention products in approximately 10% of the cases over the next decade.
Among companies that have led the growth in adhesion prevention products are Johnson & Johnson/Ethicon with its Interceed brand, and Genzyme Biosurgery, which launched Seprafilm approximately five years after the J&J product. Interceed (made out of neutralized oxidized regenerated cellulose by the company’s Noramco chemical synthesis business) and Seprafilm both provide a bioresorbable protective layer between tissues susceptible to adhesion formation.
Other contenders in this field include Omrix Biopharmaceuticals, which has developed an anti-adhesion product named Adhexil; an IND for Adhexil was filed in December 2006. Meanwhile, SyntheMed has developed the Repel-CV bioresorbable adhesion barrier; the company announced favorable results from a pivotal trial in neonatal patients in September 2006.
When Angiotech acquired Cohesion Technologies, it inherited the Adhibit sprayable adhesion prevention product. In April 2006, the company announced data from a 71-patient human clinical study (conducted in the EU) designed to assess the safety and efficacy of Adhibit for preventing adhesions in patients undergoing a myomectomy procedure. The trial data indicated that the use of Adhibit reduced post-operative adhesion. Baxter Healthcare has been granted exclusive worldwide (excluding the United States) marketing and distribution rights to Adhibit.
In July 2007, Protein Polymer Technologies (PPTI) announced it had entered into an agreement with an unnamed multinational biotechnology device company in which PPTI will provide genetically engineered protein polymer biomaterials for use in the prevention of post-surgical adhesions. PPTI believes its protein polymer materials can improve the outcome of abdominal and gynecological surgery by substantially reducing adhesions.
PPTI is also in discussions with several U.S. and international biotechnology and medical device companies, which are evaluating PPTI’s surgical sealant and drug delivery product applications. These products are intended to aid in the closure of surgical incisions and tissue trauma reducing, for example, the incidence of post-operative bleeding and the local delivery of therapeutic agents.
Market Potential
The commercial importance of wound closure and adhesion prevention products is directly linked to clinical need, which is reflected in the numbers of procedures that can benefit from improved closure and adhesion-prevention technology.
Approximately 10 million cardiovascular procedures in the United States have the potential to benefit from improved hemostasis, sealants and glue products. In an estimated 1.5 million procedures, these products can make a major contribution to the work of the surgeon in carrying out a safe procedure with minimal risk from blood transfusion and complications associated with loss of blood. Procedures that fall into this category include open heart bypass procedures with vein harvesting and many heart revascularization procedures, aortic valve replacements, mitral valve replacements, carotid endarterectomy, femoral distal bypass, and femoral popliteal bypass.
Of more than 9 million musculoskeletal surgical operations worldwide, a large number (approximately 4 million) involve minimally invasive arthroscopy or are closed fractures in which hemostats, sealants and glues cannot be used. However, open trauma cases, knee reconstruction, total knee replacement, some hip reconstruction procedures, and all spine fusion procedures have the potential to benefit from improved appropriate use of hemostat, sealants and glues. Some of these procedures cause the patient to lose substantial quantities of blood. Effective use of sealants/hemostats can prevent loss of time during surgery, reduce the requirement for replacement blood products, and significantly improve rehabilitation due to reduced morbidity.
Also there are 450,000 fusions and 432,000 discectomies performed in the United States each year. Particularly in the case of fusion, patients may require replacement of up to half the blood in their bodies. These procedures can take up to six hours to perform, and effective hemostasis can significantly improve cost effectiveness by saving surgical theater time and related costs, improving recovery and outcomes for the patient (e.g., reduced risk of infection) and reducing morbidity.
There are approximately 2.5 million joint reconstruction procedures worldwide. Although minimally invasive procedures have reduced the burden of these procedures, reconstructive surgery is likely to increase with the growth of the aging population and with increased recreational activity. These procedures can benefit from improved use of closure and hemostatic products. Typically, tourniquets are used to prevent excessive bleeding during many of these procedures; it is assumed that lack of blood flow results in morbidity of tissue and delayed recovery as well as leading to increased complications, although the reduced need for blood transfusion is thought to outweigh these disadvantages. The introduction of effective sealants and hemostats offers the possibility of selectively reducing bleeding at sites of reconstruction without the concomitant effect of increased morbidity.
It seems realistic to expect that a new category of procedure-enabling high-strength glue products will evolve and enable gluing of ligaments, tendon and bone in the orthopedic arena. Although there are a number of cement and bone graft substitute materials that have glue-like characteristics, none yet have the weight-loading potential or the torque-strength characteristics to meet the demand to fix bone fragments together without hardware support.
Gynecological and urological procedures include transurethal prostate resections, bladder surgery, prostatectomy, hysterectomy and surgical resection of adhesions, as well as cesarean sections. Hemostasis and sealing in these procedures is critical to prevent complications that can result from excessive bleeding. Neurosurgery (4 million procedures annually in the United States) is highly vulnerable to the effects associated with healing: inflammation, angiogenesis, and generation of fibrous tissue—all attributes of normal tissue repair—cause problems for neural tissue. Effective hemostasis and sealing of blood can avoid these traumatic effects and are vital to reduce morbidity.
Most traumatic wounds offer potential to be appropriately treated with hemostats, sealants and glues. Many lacerations can be adequately treated with high-strength glue products; this would avoid a secondary visit to a medical center for removal of sutures with associated costs. For example, conservative estimates of ER costs for closure of a small bleeding trauma laceration with sutures, (including local anesthetic, antibiotic cream and suture removal kit) are approximately $75 before labor and time are included. Further, in U.S. acute care hospitals, 5%–10% of patients develop hospital-acquired (nosocomial) infections, many of them in wounds. The cost per wound ranges from $3,000 to $27,000.
Revenue Implications
Fibrin-Based Sealants: The world market for fibrin-based sealants and similar products is estimated to be worth roughly $1.5 billion per annum, with annual growth rates in low double figures. Most fibrin and similar sealant products were first used for internal surgical hemostasis and sealant effects. This is now changing with the realization that appropriate hemostasis and gluing of surgical wounds results in reduced infection rates and better cosmesis. Growth rates in the synthetic and biological adhesives segment of the market will be relatively modest because these technologies have the most potential in niche opportunities, competing with established use of autologous and allogeneic fibrin products from major established players and a number of new device suppliers, as well as future recombinant human fibrin producers such as PPTI.
Fibrin sealant usage worldwide is forecast to increase steadily during the coming years, driven by such factors as the requirement to use these materials in new procedures and an increasing caseload.
One market in which these products are of special interest is Japan, where the loss of blood and avoidance of transfusion are extremely emotive issues. Growth rates here for autologous products and sealants not derived from blood may be delayed by long approval mechanisms, but will be rapid once these products appear on the Japanese market. In addition, this growth rate will be supported by the sales of new devices for the preparation of autologous fibrin sealants.
High-Strength Glues: Cyanoacrylate products are the primary form of high-strength surgical glues approved for human clinical use in the worldwide market. A number of new materials are under development for internal use in particular, but these represent new chemical entities and their commercialization is likely to be delayed by regulatory requirements.
Even though cyanoacrylate glues are not the ideal replacement for sutures, such a perfect replacement has yet to be fully developed, leaving room for cyanoacrylate glues to replace conventional sutures in many procedures over the next 10 years. To that end, cyanoacrylate glues are marketed actively by a number of companies for topical wound closure in accident/emergency situations and in surgical closure.
The $500 million world market for high-strength surgical glues is growing vigorously and expected to more than double in value over the next five years, driven by increased incidence of surgery, greater adoption of cyanoacrylate and newer adhesive products for internal surgical applications, and the need for improved, fast-acting and easy-to-use products for use in minimally invasive procedures. Also, it is increasingly recognized that these products have a role to play in reducing infection and improving cosmesis of superficial surgical wounds, which will also drive the value of this market segment.
Adhesion Prevention
The market for products to prevent post-surgical adhesions is driven by the introduction of new technologies, by impressive data on product effectiveness, by increasing caseload and by growing acceptance of this type of product. World sales of products in this category are forecast to increase by solid double-digit annual growth rates from a value around $700 million to something approaching $1.5 billion in five years’ time.
Links:Advanced Medical Solutions (Winsford, U.K.; http://www.admedsol.com/)Aesculap (Center Valley, PA; http://www.aesculap.com/)Angiotech (Vancouver, Canada; http://www.angiotech.com/)B. Braun (Melsungen, Germany; http://www.bbraun.com/)Baxter Healthcare (Deerfield, IL; http://www.baxter.com/)Chemence (Corby, U.K.; http://www.chemence.com/)Closure Medical (Raleigh, NC; http://www.closuremed.com/)Covidien (Norwalk CT; http://www.covidien.com/)CSL Behring (King of Prussia, PA; http://www.cslbehring.com/)Daiichi Sankyo (Montvale, NJ; http://www.daiichius.com/)Ethicon (Somerville, NJ; http://www.ethicon.com/)GEM (See Synovis Life Technologies)Genzyme Biosurgery (Cambridge, MA; http://www.genzyme.com/)GluStitch (Delta, Canada; http://glustitch.com/)Harvest Technologies (Plymouth, MA; http://www.harvestech.com/)Interpore Cross Medical (Irvine, CA; http://www.interpore.com/)Johnson and Johnson (Somerville, NJ; http://www.ethus.jnj.com/)Kaketsuken (Kumamoto, Japan; http://www.kaketsuken.or.jp/)MedLogic Global (See Advanced Medical Solutions)Nissui Pharmaceutical (Tokyo, Japan; http://www.nissui-pharm.co.jp/)Omrix Biopharmaceuticals (Kiryat Ono, Israel; http://www.omrix.com/)Pharming Group (Leiden, The Netherlands; http://www.pharming.com/)Plasmaseal (San Francisco, CA; http://www.plasmaseal.com/)Protein Polymer Technologies (San Diego, CA; http://www.ppti.com/)Synovis Life Technologies (St. Paul, MN; http://synovislife.com/)SyntheMed (Iselin, NJ; http://www.synthemed.com/)SysCore (E-mail: Helmut.Kranzmaier@cnc-communications.com)ThermoGenesis (Rancho Cordova, CA; http://www.thermogenesis.com/)U.S. Surgical (Norwalk, CT; http://ussurg.com/)
Acute Wounds fibrin fibrin sealant hemostasis hemostats market data medtech sealants surgery surgical sealants Surgical wounds sutures Wound closure wound management
Monday, February 11, 2008
Scarring caused by surgical gel spray
Surgical treatment hurts women but is allowed to continueBy LANE NICHOLS - The Dominion Post Monday, 11 February 2008
ANDREW GORRIE/ Dominion Post
ANGRY AND AMAZED: Hanifa Koya has stopped using SprayGel after her patients required further surgery to remove scars. She says the product should be put on hold till surgeons and patients can be assured of its safety.
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A surgical gel - containing a drug untested on humans - has caused excruciating internal scarring in dozens of women that could lead to infertility, claims a leading gynaecologist.
Many of the endometriosis patients have already forked out thousands of dollars for repeat surgery. Some are now pursuing compensation from ACC.
Endometriosis is a condition where abnormal growths develop in pelvic organs, causing inflammatory reactions leading to scarring and pain. It affects millions of women worldwide.
Though some gynaecologists have stopped using the anti-scarring gel because of concerns about its safety and effectiveness, others still use the treatment, Wellington specialist Hanifa Koya said.
Medsafe, the Government agency that approves medicines, has told the American manufacturer to add additional precautions to the instruction pamphlet.
But it maintains the product is safe, and refuses to ban its sale without conclusive evidence of harm - even though the gel is considered high risk under proposed legislation.
Dr Koya - who first raised concerns in December 2005 - was disillusioned at the response of health agencies, which she claimed had let Confluent SprayGel be used internally on thousands of Kiwi women since about 2002 without adequate clinical testing or ongoing monitoring of its effects.
She had spoken out because of concern for her patients and to highlight the need for immediate law changes to protect people.
"Confluent SprayGel is a product sprayed inside human beings and contains a section 29 drug (methylene blue) which has not been tested on human beings, and this product was allowed to be used ... [with] no quality assurance in terms of monitoring," she wrote to Medsafe in December.
"It's quite amazing - we're using it inside human beings," she told The Dominion Post. "I would have expected ... that they would have said, `Let's put this product on hold or start asking some questions', but that didn't happen."
Dr Koya began using the gel in October 2002, but stopped in April 2006 after her rate of repeat laparoscopies - keyhole operations - jumped from less than 2 per cent to around 10 per cent.
Women who would usually have made swift recoveries developed severe pain or discomfort after their initial operations.
Dozens of the many hundred women she treated with the gel needed repeat surgery to remove scarring - which could cause infertility - even though their endometriosis had not returned. "It's only where I've sprayed the SprayGel. It's like sheets of scarring which I've never seen in my practice."
Dr Koya said she had not repeated any laparoscopies since using an alternative product.
She complained to American manufacturer Confluent Surgical and has written repeatedly to MedSafe and the Health Ministry asking them to investigate, but felt her concerns had been ignored.
New Zealand distributor Covidien Tyco did not return calls.
Medsafe interim manager Stewart Jessamine said SprayGel was classed as a device under the Medicines Act, not a medicine.
No clinical assessment was required before its sale, though manufacturers had to ensure the device was safe. Medical practitioners had the ultimate responsibility for its use on patients.
After a review, it it concluded the gel was safe "when used as intended".
There had been no other complaints and there were no plans to restrict its supply, it said.
http://www.stuff.co.nz/stuff/4395993a11.html
'I shouldn't have to pay for it'The Dominion Post, New Zealand - 21 hours agoTwo years after she had invasive surgery to treat her endometriosis, Anastasia Spallas-Blades has had to go back to have painful scarring caused by a ...
Expert: Surgical gel has injured womenUnited Press International - 14 hours agoKoya said these women now suffer from endometriosis, a medical condition in which abnormal growths appear in a woman's pelvic organs. ...
Gynaecologist calls for ban on surgical gelRadio New Zealand, New Zealand - 9 hours agoA Wellington gynaecologist is calling for a ban on a gel used in operations to treat endometriosis. Hanifa Koya, a surgeon at Wellington's Wakefield ...
IHRT.....the jury is out here. We will wait for science and not accusation before we give up hope on Spraygel.
As we all were told....Spraygel is only as effective as the surgeon using it.
The blue coloring in question is used to run the bowel and bladder all the time.
Maybe they were using too many kits ( like some surgeons we know)
Science please.
ANDREW GORRIE/ Dominion Post
ANGRY AND AMAZED: Hanifa Koya has stopped using SprayGel after her patients required further surgery to remove scars. She says the product should be put on hold till surgeons and patients can be assured of its safety.
Related Links
• Subscribe to Archivestuff• Have your say
A surgical gel - containing a drug untested on humans - has caused excruciating internal scarring in dozens of women that could lead to infertility, claims a leading gynaecologist.
Many of the endometriosis patients have already forked out thousands of dollars for repeat surgery. Some are now pursuing compensation from ACC.
Endometriosis is a condition where abnormal growths develop in pelvic organs, causing inflammatory reactions leading to scarring and pain. It affects millions of women worldwide.
Though some gynaecologists have stopped using the anti-scarring gel because of concerns about its safety and effectiveness, others still use the treatment, Wellington specialist Hanifa Koya said.
Medsafe, the Government agency that approves medicines, has told the American manufacturer to add additional precautions to the instruction pamphlet.
But it maintains the product is safe, and refuses to ban its sale without conclusive evidence of harm - even though the gel is considered high risk under proposed legislation.
Dr Koya - who first raised concerns in December 2005 - was disillusioned at the response of health agencies, which she claimed had let Confluent SprayGel be used internally on thousands of Kiwi women since about 2002 without adequate clinical testing or ongoing monitoring of its effects.
She had spoken out because of concern for her patients and to highlight the need for immediate law changes to protect people.
"Confluent SprayGel is a product sprayed inside human beings and contains a section 29 drug (methylene blue) which has not been tested on human beings, and this product was allowed to be used ... [with] no quality assurance in terms of monitoring," she wrote to Medsafe in December.
"It's quite amazing - we're using it inside human beings," she told The Dominion Post. "I would have expected ... that they would have said, `Let's put this product on hold or start asking some questions', but that didn't happen."
Dr Koya began using the gel in October 2002, but stopped in April 2006 after her rate of repeat laparoscopies - keyhole operations - jumped from less than 2 per cent to around 10 per cent.
Women who would usually have made swift recoveries developed severe pain or discomfort after their initial operations.
Dozens of the many hundred women she treated with the gel needed repeat surgery to remove scarring - which could cause infertility - even though their endometriosis had not returned. "It's only where I've sprayed the SprayGel. It's like sheets of scarring which I've never seen in my practice."
Dr Koya said she had not repeated any laparoscopies since using an alternative product.
She complained to American manufacturer Confluent Surgical and has written repeatedly to MedSafe and the Health Ministry asking them to investigate, but felt her concerns had been ignored.
New Zealand distributor Covidien Tyco did not return calls.
Medsafe interim manager Stewart Jessamine said SprayGel was classed as a device under the Medicines Act, not a medicine.
No clinical assessment was required before its sale, though manufacturers had to ensure the device was safe. Medical practitioners had the ultimate responsibility for its use on patients.
After a review, it it concluded the gel was safe "when used as intended".
There had been no other complaints and there were no plans to restrict its supply, it said.
http://www.stuff.co.nz/stuff/4395993a11.html
'I shouldn't have to pay for it'The Dominion Post, New Zealand - 21 hours agoTwo years after she had invasive surgery to treat her endometriosis, Anastasia Spallas-Blades has had to go back to have painful scarring caused by a ...
Expert: Surgical gel has injured womenUnited Press International - 14 hours agoKoya said these women now suffer from endometriosis, a medical condition in which abnormal growths appear in a woman's pelvic organs. ...
Gynaecologist calls for ban on surgical gelRadio New Zealand, New Zealand - 9 hours agoA Wellington gynaecologist is calling for a ban on a gel used in operations to treat endometriosis. Hanifa Koya, a surgeon at Wellington's Wakefield ...
IHRT.....the jury is out here. We will wait for science and not accusation before we give up hope on Spraygel.
As we all were told....Spraygel is only as effective as the surgeon using it.
The blue coloring in question is used to run the bowel and bladder all the time.
Maybe they were using too many kits ( like some surgeons we know)
Science please.
Cardiovascular Sciences, Inc. Agrees to Terms With the University of Central Florida
ORLANDO, FL, Feb 05, 2008 (MARKET WIRE via COMTEX) -- Cardiovascular Sciences, Inc. (PINKSHEETS: CVSC) announced today that following the recent funding event, the Company has been able to reach an agreement with the University of Central Florida to continue the Company's research and development on its post-surgical anti-adhesion technology. Adhesions occur after surgery when two normally separate but adjacent tissues that have been injured or stressed scar together. Adhesions are part of the normal healing process, but when they occur between tissues that are not normally attached, problems ranging from mild discomfort to life threatening intestinal obstruction can occur. The global market to address the problem of adhesions and adhesion related complications exceeds $6 billion.
ORLANDO, FL, Feb 05, 2008 (MARKET WIRE via COMTEX) -- Cardiovascular Sciences, Inc. (PINKSHEETS: CVSC) announced today that following the recent funding event, the Company has been able to reach an agreement with the University of Central Florida to continue the Company's research and development on its post-surgical anti-adhesion technology. Adhesions occur after surgery when two normally separate but adjacent tissues that have been injured or stressed scar together. Adhesions are part of the normal healing process, but when they occur between tissues that are not normally attached, problems ranging from mild discomfort to life threatening intestinal obstruction can occur. The global market to address the problem of adhesions and adhesion related complications exceeds $6 billion.
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