Baxter Recalls All Heparin Vial Products
Written by Catharine Paddock, PhD
Baxter International Inc announced yesterday, Thursday 28th February, that it was recalling all remaining multi-dose and single-dose heparin sodium and HEP -LOCK heparin flush products now that alternative suppliers are able to meet national demand for them...[read article]
Peer-Reviewed Science Must Be The Source For Policy Decisions Regarding Drug Harm-Reduction
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The Critically Ill May Be Harmed By Intensive Insulin Therapy
State-To-State Differences In Quality Of Care Revealed By New Child Health Data
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AMA Denounces Erosion Of Insurer Competition, USA
New National Poll: Majority Of American Voters Oppose Bush Administration's Proposed Cuts To Medicare
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Democratic Presidential Candidates Clinton, Obama Discuss Plans To Expand Health Coverage During Ohio Debate
Health Insurers Work To Address Issues Involving Retroactively Canceled Policies
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Friday, February 29, 2008
Polycystic Ovary Syndrome PCOS
PCOD is a female hormonal imbalance where maturing eggs fail to be expelled from the ovary, creating an ovary filled with immature follicles. The cysts then contribute to the hormonal imbalance, which causes more cysts and enlarged ovaries. Polycystic ovary disease is characterized by anovulation (no formation of egg) irrespective of periods (regular or irregular or absent) and hyperandrogenism (elevated serum testosterone and androgen). Also women with PCOD who conceive have a higher rate of early foetal loss than women without PCOD.
PCOD women have fewer chances to conceive, compared to normal women who ovulate every month. Normal women get 12chances in a year to conceive. But PCOD women hardly get 3-4 chances due to delayed periods.
Relative causes of PCOD
PCOD does run in families. Several genes contribute to the pathogenesis of PCOD. Many of these genes are related to insulin resistance with elevated fasting blood insulin levels. The high levels of androgenic hormones interfere with the pituitary ovarian axis, leading to increased LH levels, anovulation, amenorrhea and infertility.
Young diabetic women treated with insulin are at special risk of PCOD. The amount of insulin injected by insulin-dependent or insulin-requiring diabetics is far in excess of what the body produces naturally.
Obesity is a common part of PCOD and many of these women are also insulin-resistant. When a woman is insulin-resistant, her fat cell does not respond normally to the insulin in the blood stream. Weight gain in itself can result from high serum insulin levels.
Symptoms of PCOD
The most common symptoms of PCOD are
Irregular and infrequent menstrual periods or no menstrual periods at all;
Infrequent or no ovulation with increased serum levels of male hormones - testosterone;
Inability to get pregnant within one year of unprotected sexual intercourse;
Weight gain or obesity;
Diabetes, over-production of insulin with abnormal lipid levels and high blood pressure;
Excess growth of hair on the face, chest, stomach in male pattern (hirsutism) and male-pattern baldness or thinning of hair;Acne, oily skin or dandruff;
Patches of thickened and dark brown or black skin on the neck, groin, underarms, or skin folds;
Skin tags, or tiny excess flaps of skin in the armpits or neck area;
Male fat storage patterns - abdominal storage rather than standard female pattern on thighs, hips and waist; and Mid-cycle pain indicating painful ovulation - due to the enlargement and blockage of the surface of the ovaries;
Consequences of PCOD
Hyperinsulinemia in PCOD has also been associated with high blood pressure and increased clot formation and appears to be a major risk factor for the development of heart disease, stroke and type-II diabetes
Women with irregular cycles need to have other conditions ruled out, such as anorexia, stress or exercise-induced problems with the menstrual cycle, other hormonal problems such as thyroid disease or medication problems.
The general consequences of PCOD are:Menstrual irregularities - Constant oestrogen production stimulates growth of the uterine lining which usually induces very heavy uterine bleeding. The bleeding episodes may occur after long gaps of time (oligomenorrhea) or, for some women, not at all (amenorrhea). Irregular periods are a nuisance and suggest some hormonal disorder or risk of endometrial thickening.
Impaired Fertility- Another consequence of incomplete follicular development is a lack of regular ovulation. Irregular ovulation usually means that pregnancy is more difficult to achieve. Similarly, if ovulation is not taking place, it is not possible to conceive.
Miscarriage - While miscarriage seems an unfortunate chance event for most couples, it is clear that women with PCOD may be at increased risk of early foetal loss. The hormonal environment in PCOD may interfere with egg development within the follicle and disrupt embryo implantation within the uterus.
Hair and skin problems - Androgen (male hormone) is a byproduct of the ovaries. In PCOD, the production of androgen, such as testosterone, is excessive, which causes abnormally increased hair growth and contributes to acne formation. The assessment of excessive hair growth (or hirsutism) may be difficult.
Obesity - About 50 per cent of women with PCOD are obese. Obesity tends to enhance abnormal estrogen and androgen production in this disorder, which only magnifies the problems of irregular bleeding and excessive hair growth.
More important, the long-term effects of unopposed oestrogen place women with the syndrome at considerable risk for endometrial cancer or breast cancer.
Diagnosis of PCOD - The signs of PCOD are ovaries slightly enlarged and may contain 10 or more small cysts located at the periphery of the ovary, which have led to polycystic ovaries. The size of these cysts is generally less than 8 mm and can usually be detected by ultrasound examination. Pelvic and physical examination, ultra sound scanning, blood tests to measure hormone, insulin and cholesterol levels will also help. Height and weight will be noted along with any increase in facial or body hair or loss of scalp hair, acne and discoloration of the skin under the arms, breasts and in the groin. Elevated androgen levels or testosterone confirms the diagnosis.
General treatment for PCOD
Mostly patients take treatment for cosmetic ailments like obesity, unwanted hair growth or acne. They will not mind the underlying delayed and heavy periods which is to be treated first. Medical treatment should be given to correct irregular menstruation, eradicate excessive hair growth or achieve pregnancy.
Because there is no cure for PCOD in Allopathy, it concentrates on ways of management to prevent further problems. The treatment can be as:
Medication: To induce a menstrual period and restore normal cycles, birth control pills are used. It regulates menstruation, reduces androgen levels and helps to clear acne. The method of treatment depends on the severity of the symptoms and whether the patient is trying to get pregnant or not. If not trying to conceive, then they are treated with hormones, including the birth control pill. If trying to become pregnant, fertility drugs and other treatments are necessary.
Getting normal can be tried:
1) Eating a balanced diet low in carbohydrates and maintaining a healthy weight can help lessen the symptoms of PCOD.2) Regular exercise helps weight loss and also helps the body in reducing blood glucose levels. Aerobic activities such as walking, jogging or swimming are advised. With reduction of weight and reduction in insulin resistance, regular periods will mostly resume. It is not always possible to promise a woman who has achieved ideal body weight and who continues with exercise that she may have regular ovulation.3) For reducing excess body and facial hair, bleaching, removal by waxing or a hair removal cream can be used. For permanent facial hair removal, electrolysis is done.
Treatment of PCOD for the infertile patient will usually focus on ovulation inducting. They induce ovulation with fertility drugs. Sometimes fertility drugs may induce risk of multiple pregnancies.
Surgery: Doctors used to perform ovarian surgery called wedge re-section to help patients with PCOD to ovulate. A recent treatment option uses laparoscopy to treat patients with PCOD. During operative laparoscopy, a laser is used to drill multiple holes through the thickened ovarian capsule. When wedge re-section or drilling is used, there is risk of inducing adhesions around the ovary. As a result of these, surgeries are used as the last resort.
Related
Naomi Campbell fine after cyst operationThe Sun, UK - Feb 27, 2008
Polycystic Ovary Syndrome (PCOS) – where there are several cysts – is a more serious condition associated with hormonal abnormalities. ...
PCOD women have fewer chances to conceive, compared to normal women who ovulate every month. Normal women get 12chances in a year to conceive. But PCOD women hardly get 3-4 chances due to delayed periods.
Relative causes of PCOD
PCOD does run in families. Several genes contribute to the pathogenesis of PCOD. Many of these genes are related to insulin resistance with elevated fasting blood insulin levels. The high levels of androgenic hormones interfere with the pituitary ovarian axis, leading to increased LH levels, anovulation, amenorrhea and infertility.
Young diabetic women treated with insulin are at special risk of PCOD. The amount of insulin injected by insulin-dependent or insulin-requiring diabetics is far in excess of what the body produces naturally.
Obesity is a common part of PCOD and many of these women are also insulin-resistant. When a woman is insulin-resistant, her fat cell does not respond normally to the insulin in the blood stream. Weight gain in itself can result from high serum insulin levels.
Symptoms of PCOD
The most common symptoms of PCOD are
Irregular and infrequent menstrual periods or no menstrual periods at all;
Infrequent or no ovulation with increased serum levels of male hormones - testosterone;
Inability to get pregnant within one year of unprotected sexual intercourse;
Weight gain or obesity;
Diabetes, over-production of insulin with abnormal lipid levels and high blood pressure;
Excess growth of hair on the face, chest, stomach in male pattern (hirsutism) and male-pattern baldness or thinning of hair;Acne, oily skin or dandruff;
Patches of thickened and dark brown or black skin on the neck, groin, underarms, or skin folds;
Skin tags, or tiny excess flaps of skin in the armpits or neck area;
Male fat storage patterns - abdominal storage rather than standard female pattern on thighs, hips and waist; and Mid-cycle pain indicating painful ovulation - due to the enlargement and blockage of the surface of the ovaries;
Consequences of PCOD
Hyperinsulinemia in PCOD has also been associated with high blood pressure and increased clot formation and appears to be a major risk factor for the development of heart disease, stroke and type-II diabetes
Women with irregular cycles need to have other conditions ruled out, such as anorexia, stress or exercise-induced problems with the menstrual cycle, other hormonal problems such as thyroid disease or medication problems.
The general consequences of PCOD are:Menstrual irregularities - Constant oestrogen production stimulates growth of the uterine lining which usually induces very heavy uterine bleeding. The bleeding episodes may occur after long gaps of time (oligomenorrhea) or, for some women, not at all (amenorrhea). Irregular periods are a nuisance and suggest some hormonal disorder or risk of endometrial thickening.
Impaired Fertility- Another consequence of incomplete follicular development is a lack of regular ovulation. Irregular ovulation usually means that pregnancy is more difficult to achieve. Similarly, if ovulation is not taking place, it is not possible to conceive.
Miscarriage - While miscarriage seems an unfortunate chance event for most couples, it is clear that women with PCOD may be at increased risk of early foetal loss. The hormonal environment in PCOD may interfere with egg development within the follicle and disrupt embryo implantation within the uterus.
Hair and skin problems - Androgen (male hormone) is a byproduct of the ovaries. In PCOD, the production of androgen, such as testosterone, is excessive, which causes abnormally increased hair growth and contributes to acne formation. The assessment of excessive hair growth (or hirsutism) may be difficult.
Obesity - About 50 per cent of women with PCOD are obese. Obesity tends to enhance abnormal estrogen and androgen production in this disorder, which only magnifies the problems of irregular bleeding and excessive hair growth.
More important, the long-term effects of unopposed oestrogen place women with the syndrome at considerable risk for endometrial cancer or breast cancer.
Diagnosis of PCOD - The signs of PCOD are ovaries slightly enlarged and may contain 10 or more small cysts located at the periphery of the ovary, which have led to polycystic ovaries. The size of these cysts is generally less than 8 mm and can usually be detected by ultrasound examination. Pelvic and physical examination, ultra sound scanning, blood tests to measure hormone, insulin and cholesterol levels will also help. Height and weight will be noted along with any increase in facial or body hair or loss of scalp hair, acne and discoloration of the skin under the arms, breasts and in the groin. Elevated androgen levels or testosterone confirms the diagnosis.
General treatment for PCOD
Mostly patients take treatment for cosmetic ailments like obesity, unwanted hair growth or acne. They will not mind the underlying delayed and heavy periods which is to be treated first. Medical treatment should be given to correct irregular menstruation, eradicate excessive hair growth or achieve pregnancy.
Because there is no cure for PCOD in Allopathy, it concentrates on ways of management to prevent further problems. The treatment can be as:
Medication: To induce a menstrual period and restore normal cycles, birth control pills are used. It regulates menstruation, reduces androgen levels and helps to clear acne. The method of treatment depends on the severity of the symptoms and whether the patient is trying to get pregnant or not. If not trying to conceive, then they are treated with hormones, including the birth control pill. If trying to become pregnant, fertility drugs and other treatments are necessary.
Getting normal can be tried:
1) Eating a balanced diet low in carbohydrates and maintaining a healthy weight can help lessen the symptoms of PCOD.2) Regular exercise helps weight loss and also helps the body in reducing blood glucose levels. Aerobic activities such as walking, jogging or swimming are advised. With reduction of weight and reduction in insulin resistance, regular periods will mostly resume. It is not always possible to promise a woman who has achieved ideal body weight and who continues with exercise that she may have regular ovulation.3) For reducing excess body and facial hair, bleaching, removal by waxing or a hair removal cream can be used. For permanent facial hair removal, electrolysis is done.
Treatment of PCOD for the infertile patient will usually focus on ovulation inducting. They induce ovulation with fertility drugs. Sometimes fertility drugs may induce risk of multiple pregnancies.
Surgery: Doctors used to perform ovarian surgery called wedge re-section to help patients with PCOD to ovulate. A recent treatment option uses laparoscopy to treat patients with PCOD. During operative laparoscopy, a laser is used to drill multiple holes through the thickened ovarian capsule. When wedge re-section or drilling is used, there is risk of inducing adhesions around the ovary. As a result of these, surgeries are used as the last resort.
Related
Naomi Campbell fine after cyst operationThe Sun, UK - Feb 27, 2008
Polycystic Ovary Syndrome (PCOS) – where there are several cysts – is a more serious condition associated with hormonal abnormalities. ...
Wednesday, February 27, 2008
Adhesions news ARDvark Blog
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EndoGastric Solutions(TM) Announces Results Of EsophyX(TM) Multi-Center GERD Study
Bacterial 'Battle For Survival' Leads To New Antibiotic - Holds Promise For Treating Stomach Ulcers
Causes Of, Risk Factors For Pelvic Floor Injury To Be Determined By OHSU Researcher, Funded By NIH Award
News From The Journal Of Neuroscience
Botox Examined By U Of C Researchers In New Study
ITrials Launches New Technology To Identify Clinical Trial Risks Before Significant Recruiting Investments Are Made
Kohl To Examine Medical Device Industry Practice Of Providing Payments To Surgeons, USA
Tips For Troublesome Medications, From The Harvard Heart Letter
Baby Boomers Confused About Medicare, According To Recent NAIC Survey
Researchers Identify And Shut Down Protein That Fuels Ovarian Cancer
Researchers Engineer First System Of Human Nerve Cell Tissue
Risks Of CVD For COX 2 Inhibitors Lower Than Previously Reported
Prophylactic nasogastric decompression after abdominal surgery
Nelson R, Edwards S, Tse B
Summary
Nasogastric decompression used routinely after abdominal surgery does not speed recovery.This systematic review of 33 trials showed that routine use of nasogastric tube decompression after abdominal operations, rather than speeding recovery, may slow recovery down and increase the risk of some postoperative complications. On the other hand routine use may decrease the risk of wound infection and subsequent ventral hernia.
This is a Cochrane review abstract and plain language summary, prepared and maintained by The Cochrane Collaboration, currently published in The Cochrane Database of Systematic Reviews 2008 Issue 1, Copyright © 2008 The Cochrane Collaboration. Published by John Wiley and Sons, Ltd.. The full text of the review is available in The Cochrane Library (ISSN 1464-780X).This record should be cited as: Nelson R, Edwards S, Tse B. Prophylactic nasogastric decompression after abdominal surgery. Cochrane Database of Systematic Reviews 2005, Issue 1. Art. No.: CD004929. DOI: 10.1002/14651858.CD004929.pub3
This version first published online: January 24. 2005Date of last subtantive update: April 17. 2007
Abstract
Background
Routine use of nasogastric tubes after abdominal operations is intended to hasten the return of bowel function, prevent pulmonary complications, diminish the risk of anastomotic leakage, increase patient comfort and shorten hospital stay.
Objectives
To investigate the efficacy of routine nasogastric decompression after abdominal surgery in achieving each of the above goals.
Search strategy
Search terms were nasogastric, tubes, randomised, using MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials (Central), and references of included studies, from 1966 through 2006.
Selection criteria
Patients having abdominal operations of any type, emergency or elective, who were randomised prior tot he completion of the operation to receive a nasogastric tube and keep it in place until intestinal function had returned, versus those receiving either no tube or early tube removal, in surgery, in recovery or within 24 hours of surgery. Excluded will be randomised studies involving laparoscopic abdominal surgery and patient groups having gastric decompression through gastrostomy.
Data collection and analysis
Data were abstracted onto a form that assessed study eligibility, as defined above, quality related to randomizations, allocation concealment, study size and dropouts, interventions, including timing and duration of intubation, outcomes that included time to flatus, pulmonary complications, wound infection, anastomotic leak, length of stay, death, nausea, vomit ting, tube reinsertion, subsequent ventral hernia.
Main results
33 studies fulfilled eligibility criteria, encompassing 5240 patients, 2628 randomised to routine tube use, and 2612 randomised to selective or No Tube use. Patients not having routine tube use had an earlier return of bowel function (p<0.00001), a decrease in pulmonary complications (p=0.01) and an insignificant trend toward increase in risk of wound infection (p=0.22) and ventral hernia (0.09). Anastomotic leak was no different between groups (p=0.70). Vomit ting seemed to favour routine tube use, but with increased patient discomfort. Length of stay was shorter when no tube was used but the heterogeneity encountered in these analyses make rigorous conclusion difficult to draw for this outcome. No adverse events specifically related to tube insertion (direct tube trauma) were reported. Other outcomes were reported with insufficient frequency to be informative.
Authors' conclusions
Routine nasogastric decompression does not accomplish any of its intended goals and so should be abandoned in favour of selective use of the nasogastric tube.
Surgery Archive
Summary
Nasogastric decompression used routinely after abdominal surgery does not speed recovery.This systematic review of 33 trials showed that routine use of nasogastric tube decompression after abdominal operations, rather than speeding recovery, may slow recovery down and increase the risk of some postoperative complications. On the other hand routine use may decrease the risk of wound infection and subsequent ventral hernia.
This is a Cochrane review abstract and plain language summary, prepared and maintained by The Cochrane Collaboration, currently published in The Cochrane Database of Systematic Reviews 2008 Issue 1, Copyright © 2008 The Cochrane Collaboration. Published by John Wiley and Sons, Ltd.. The full text of the review is available in The Cochrane Library (ISSN 1464-780X).This record should be cited as: Nelson R, Edwards S, Tse B. Prophylactic nasogastric decompression after abdominal surgery. Cochrane Database of Systematic Reviews 2005, Issue 1. Art. No.: CD004929. DOI: 10.1002/14651858.CD004929.pub3
This version first published online: January 24. 2005Date of last subtantive update: April 17. 2007
Abstract
Background
Routine use of nasogastric tubes after abdominal operations is intended to hasten the return of bowel function, prevent pulmonary complications, diminish the risk of anastomotic leakage, increase patient comfort and shorten hospital stay.
Objectives
To investigate the efficacy of routine nasogastric decompression after abdominal surgery in achieving each of the above goals.
Search strategy
Search terms were nasogastric, tubes, randomised, using MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials (Central), and references of included studies, from 1966 through 2006.
Selection criteria
Patients having abdominal operations of any type, emergency or elective, who were randomised prior tot he completion of the operation to receive a nasogastric tube and keep it in place until intestinal function had returned, versus those receiving either no tube or early tube removal, in surgery, in recovery or within 24 hours of surgery. Excluded will be randomised studies involving laparoscopic abdominal surgery and patient groups having gastric decompression through gastrostomy.
Data collection and analysis
Data were abstracted onto a form that assessed study eligibility, as defined above, quality related to randomizations, allocation concealment, study size and dropouts, interventions, including timing and duration of intubation, outcomes that included time to flatus, pulmonary complications, wound infection, anastomotic leak, length of stay, death, nausea, vomit ting, tube reinsertion, subsequent ventral hernia.
Main results
33 studies fulfilled eligibility criteria, encompassing 5240 patients, 2628 randomised to routine tube use, and 2612 randomised to selective or No Tube use. Patients not having routine tube use had an earlier return of bowel function (p<0.00001), a decrease in pulmonary complications (p=0.01) and an insignificant trend toward increase in risk of wound infection (p=0.22) and ventral hernia (0.09). Anastomotic leak was no different between groups (p=0.70). Vomit ting seemed to favour routine tube use, but with increased patient discomfort. Length of stay was shorter when no tube was used but the heterogeneity encountered in these analyses make rigorous conclusion difficult to draw for this outcome. No adverse events specifically related to tube insertion (direct tube trauma) were reported. Other outcomes were reported with insufficient frequency to be informative.
Authors' conclusions
Routine nasogastric decompression does not accomplish any of its intended goals and so should be abandoned in favour of selective use of the nasogastric tube.
Surgery Archive
Cardiovascular Sciences, Inc. Consolidates Progress and Forges Ahead
SOURCE: Cardiovascular Sciences
Feb 19, 2008 08:18 ET
ORLANDO, FL--(Marketwire - February 19, 2008) - Cardiovascular Sciences, Inc. (PINKSHEETS: CVSC) was established a few years ago to investigate and develop novel medical technologies to meet unmet and only partially addressed clinical needs. Areas of endeavor have required technologies as wide ranging as cell engineering to clot resistant coatings to tissue grafts to guided radiofrequency ablators and more. But what gradually became evident to the Company's technical team as they considered a variety of factors such as the size and growth of the ultimate market, the shortfalls of available products for this need, and the resources and time required to develop a likely technology to marketability, there was one clinical need that trumped the other areas. That is the need to prevent adhesions and adhesion related complications that often follow various surgeries and traumas. The cost of these complications constitutes a $6+ billion global market.
The adhesion process is part of normal healing and is what allows the edges of a cut on the skin to knit together and heal. But when two adjacent tissues that are not normally attached are stressed as happens in most surgeries, the surfaces can scar together and contract, causing problems ranging from minor discomfort to joint limitation to life threatening obstruction and intestinal perforation. The key to preventing this is to use a material to separate the surfaces for several days that then degrades and reabsorbs after the healing has reached the point after which adhesions are unlikely to occur.
Focusing on this need has allowed the team to consolidate its resources and efforts in the most productive area. A new president with market development experience was brought in, Mr. Eric O. Edelmann, who remains as a consultant. Larry Hooper, a physician, was moved into the top spot as CEO, directed and coordinated the team's research at the University of Central Florida. Along with this, the Company was admitted into UCF's award winning Technology Incubator program where it has garnered much praise as evidenced by Gordon Hogan, the incubator's Business Development Executive, "It is exciting to watch Cardiovascular Sciences leverage their existing management strengths with the scientific and technological strengths of UCF. This convergence can easily result in dramatic changes in the prevention of surgical adhesions." Carol Ann Dykes, the incubator's Technology Site Manager is similarly enthused. "It's been exciting to watch this committed and passionate team pull it together and march toward what promises to be an exciting and successful future."
"Rightly or wrongly," explains the company's CEO, "the company did spend considerable effort chasing and investigating a wide range of technologies." But Dr. Hooper hastens to add, "But if not for that, we would not have found, developed and understood the value of the technology we now have. And by intently focusing in this area, the range of indications and other possible uses of the second generation material we have produced continue to blossom well beyond what we first envisioned."
The recent funding event announced with Seven Palm Investments, LLC now allows the company to intensify its efforts and move into high gear with its R & D. This next year should see an increasing frequency of announcements as the Company continues to develop an even wider variety of applications for its products, and commences expanded in vitro and animal trials as it relentlessly pursues the course to marketing its proprietary technology.
About Cardiovascular Sciences
Cardiovascular Sciences, Inc. is an advanced medical device company which is developing a novel technology platform to address the problem of post-surgical and post-traumatic adhesions. Adhesions and the complications of adhesions are a significant problem worldwide for a wide range of specialists, including general surgeons, cardiothoracic surgeons, orthopedic, plastic, and ophthalmologic and otolaryngology specialists to name just some of them. In addition, the veterinary field has a tremendous need for a product that can prevent similar problems in a wide variety of animals.
The Company's unique materials and processes promise a more cost-effective and decidedly more efficient and capable means to deal with a problem that has been so devastating to so many. Current sponsored research at the University of Central Florida (UCF) and previously at other institutions indicate that The Company is on the right path and progressing well.
In addition to the anti-adhesion technology, The Company owns technology in a variety of other areas, including thrombo-resistant coatings, enhanced intra-arterial balloon pumping catheters, cell engineered vascular tissues, and a method for improved recovery of the heart following cardioplegia. This yields a diversified portfolio with projects in various stages of development. www.cvsciences.org
Forward-looking statements in this release are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to certain risks, and uncertainties and actual results could differ from those discussed. This material is information only and is not an offer or solicitation to buy or sell the securities.
Feb 19, 2008 08:18 ET
ORLANDO, FL--(Marketwire - February 19, 2008) - Cardiovascular Sciences, Inc. (PINKSHEETS: CVSC) was established a few years ago to investigate and develop novel medical technologies to meet unmet and only partially addressed clinical needs. Areas of endeavor have required technologies as wide ranging as cell engineering to clot resistant coatings to tissue grafts to guided radiofrequency ablators and more. But what gradually became evident to the Company's technical team as they considered a variety of factors such as the size and growth of the ultimate market, the shortfalls of available products for this need, and the resources and time required to develop a likely technology to marketability, there was one clinical need that trumped the other areas. That is the need to prevent adhesions and adhesion related complications that often follow various surgeries and traumas. The cost of these complications constitutes a $6+ billion global market.
The adhesion process is part of normal healing and is what allows the edges of a cut on the skin to knit together and heal. But when two adjacent tissues that are not normally attached are stressed as happens in most surgeries, the surfaces can scar together and contract, causing problems ranging from minor discomfort to joint limitation to life threatening obstruction and intestinal perforation. The key to preventing this is to use a material to separate the surfaces for several days that then degrades and reabsorbs after the healing has reached the point after which adhesions are unlikely to occur.
Focusing on this need has allowed the team to consolidate its resources and efforts in the most productive area. A new president with market development experience was brought in, Mr. Eric O. Edelmann, who remains as a consultant. Larry Hooper, a physician, was moved into the top spot as CEO, directed and coordinated the team's research at the University of Central Florida. Along with this, the Company was admitted into UCF's award winning Technology Incubator program where it has garnered much praise as evidenced by Gordon Hogan, the incubator's Business Development Executive, "It is exciting to watch Cardiovascular Sciences leverage their existing management strengths with the scientific and technological strengths of UCF. This convergence can easily result in dramatic changes in the prevention of surgical adhesions." Carol Ann Dykes, the incubator's Technology Site Manager is similarly enthused. "It's been exciting to watch this committed and passionate team pull it together and march toward what promises to be an exciting and successful future."
"Rightly or wrongly," explains the company's CEO, "the company did spend considerable effort chasing and investigating a wide range of technologies." But Dr. Hooper hastens to add, "But if not for that, we would not have found, developed and understood the value of the technology we now have. And by intently focusing in this area, the range of indications and other possible uses of the second generation material we have produced continue to blossom well beyond what we first envisioned."
The recent funding event announced with Seven Palm Investments, LLC now allows the company to intensify its efforts and move into high gear with its R & D. This next year should see an increasing frequency of announcements as the Company continues to develop an even wider variety of applications for its products, and commences expanded in vitro and animal trials as it relentlessly pursues the course to marketing its proprietary technology.
About Cardiovascular Sciences
Cardiovascular Sciences, Inc. is an advanced medical device company which is developing a novel technology platform to address the problem of post-surgical and post-traumatic adhesions. Adhesions and the complications of adhesions are a significant problem worldwide for a wide range of specialists, including general surgeons, cardiothoracic surgeons, orthopedic, plastic, and ophthalmologic and otolaryngology specialists to name just some of them. In addition, the veterinary field has a tremendous need for a product that can prevent similar problems in a wide variety of animals.
The Company's unique materials and processes promise a more cost-effective and decidedly more efficient and capable means to deal with a problem that has been so devastating to so many. Current sponsored research at the University of Central Florida (UCF) and previously at other institutions indicate that The Company is on the right path and progressing well.
In addition to the anti-adhesion technology, The Company owns technology in a variety of other areas, including thrombo-resistant coatings, enhanced intra-arterial balloon pumping catheters, cell engineered vascular tissues, and a method for improved recovery of the heart following cardioplegia. This yields a diversified portfolio with projects in various stages of development. www.cvsciences.org
Forward-looking statements in this release are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to certain risks, and uncertainties and actual results could differ from those discussed. This material is information only and is not an offer or solicitation to buy or sell the securities.
Pelvic inflammatory disease
Pelvic inflammatory disease (or disorder) (PID) is a generic term for inflammation of the female uterus, fallopian tubes, and/or ovaries as it progresses to scar formation with adhesions to nearby tissues and organs. This may lead to tissue necrosis with/or without abscess formation. Pus can be released into the peritoneum. Two thirds of patients with laparoscopic evidence of previous PID were not aware they had had PID.[1] PID is often associated with sexually transmitted diseases, as it is a common result of such infections. PID is a vague term and can refer to viral, fungal, parasitic, though most often bacterial infections. PID should be classified by affected organs, the stage of the infection, and the organism(s) causing it. Although an STD is often the cause, other routes are possible, including lymphatic, postpartum, postabortal (either miscarriage or abortion) or intrauterine device (IUD) related, and hematogenous spread.
Epidemiology
In the United States, more than one million women are affected by PID each year, and the rate is highest with teenagers. Over 100,000 women become infertile in the US each year from PID.[2] N. gonorrhoea is isolated in only 40-60% of women with acute salpingitis.[3] C. trachomatis was estimated by current obgyn 9th ed to be the cause in about 60% of cases of salpingitis, which may lead to PID. It is unsure how much is due to a single organism and how much is due to multiple organisms; many other pathogens that are in normal vaginal flora become involved in PID. 10% of women in one study had asymptomatic Chlamydia trachomatis infection and 65% had asymptomatic infection with Neisseria gonorrhoeae.[3] It was noted in one study that 10-40% of untreated women with N. gonorrhoea develop PID and 20-40% of women infected with C. trachomitis developed PID.[1] PID is the leading cause of infertility. "A single episode of PID results in infertility in 13% of women."[1] This rate of infertility increases with each infection.
Diagnosis
There may be no actual symptoms of PID. If there are symptoms then fever, cervical motion tenderness, lower abdominal pain, new or different discharge, painful intercourse, or irregular menstrual bleeding may be noted. It is important to note that PID can occur and cause serious harm without causing any noticeable symptoms. Laparoscopic identification is helpful in diagnosing tubal disease, 65-90% positive predictive value in patients with presumed PID.[3] Regular Sexually transmitted disease (STD) testing is important for prevention. Treatment is usually started empirically because of the terrible complications. Definitive criteria include: histopathologic evidence of endometritis, thickened filled fallopian tubes, or laparoscopic findings. Gram-stain/smear becomes important in identification of rare and possibly more serious organisms.[1]
Differential diagnosis
Appendicitis, ectopic pregnancy, septic abortion, hemorrhagic or ruptured ovarian cysts or tumors, twisted ovarian cyst, degeneration of a myoma, and acute enteritis must be considered. Pelvic inflammatory disease is more likely to occur when there is a history of pelvic inflammatory disease, recent sexual contact, recent onset of menses, or an IUD in place or if the partner has a sexually transmitted disease.
Acute pelvic inflammatory disease is highly unlikely when recent intercourse has not taken place or an IUD is not being used. A sensitive serum pregnancy test should be obtained to rule out ectopic pregnancy. Culdocentesis will differentiate hemoperitoneum (ruptured ectopic pregnancy or hemorrhagic cyst) from pelvic sepsis (salpingitis, ruptured pelvic abscess, or ruptured appendix).
Pelvic and vaginal ultrasounds are helpful in the differential diagnosis of ectopic pregnancy of over six weeks. Laparoscopy is often utilized to diagnose pelvic inflammatory disease, and it is imperative if the diagnosis is not certain or if the patient has not responded to antibiotic therapy after 48 hours.
No single test has adequate sensitivity and specificity to diagnose pelvic inflammatory disease. A large mulitsite U.S. study found that cervical motion tenderness as a minimum clinical criterion increases the sensitivity of the CDC diagnostic criteria from 83% to 95%. However, even the modified 2002 CDC criteria does not identify women with subclinical disease.[4]
Prognosis
Although the PID infection itself may be cured, effects of the infection may be permanent. This makes early identification by someone who can prescribe appropriate curative treatment so important in the prevention of damage to the reproductive system. Since early gonococcal infection may be asymptomatic, regular screening of individuals at risk for common agents (history of multiple partners, history of any unprotected sex, or people with symptoms) or because of certain procedures (post pelvic operation, postpartum, miscarriage or abortion). Prevention is also very important in maintaining viable reproduction capabilities.
If the initial infection is mostly in the lower tract, after treatment the person may have few difficulties. If the infection is in the fallopian tubes or ovaries, more serious complications are more likely to occur.
Complications
PID can cause scarring inside the reproductive organs, which can later cause serious complications, including chronic pelvic pain, infertility (difficulty becoming pregnant), ectopic pregnancy (the leading cause of pregnancy-related deaths in adult females), and other dangerous complications of pregnancy. Multiple infections and infections that are treated later are more likely to result in complications.
Infertile women may wish to see a specialist, because there may be a possibility in restoring fertility after scarring. Traditionally tuboplastic surgery was the main approach to correct tubal obstruction or adhesion formation, however success rates tended to be very limited. In vitro fertilization (IVF) was developed to bypass tubal problems and has become the main treatment for patients who want to become pregnant.
Treatment
Treatment depends on the cause and generally involves use of antibiotic therapy. If the patient has not improved within two to three days after beginning treatment with the antibiotics, they should return to the hospital for further treatment. Drugs should also be given orally and/or intravaneously to the patient while in the hospital to begin treatment immediately to increase the effectiveness of antibiotic treatment. Hospitalization may be necessary if Tubo-ovarian abscess, very ill, immunodeficient, pregnancy, incompetence, or because this or something else life threatening can not be ruled out. Treating partners for STD's is a very important part of treatment and prevention. Anyone with PID and partners of patients with PID since six months prior to diagnosis should be treated to prevent reinfection. Psychotherapy is highly recommended to women diagnosed with PID as the fear of redeveloping the disease after being cured may exist. It is important for a patient to communicate any issues and/or uncertainties they may have to a doctor, especially a specialist such as a gynecologist, and in doing so, to seek follow-up care.
A systematic review of the literature related to PID treatment was performed prior to the 2006 CDC sexually transmitted diseases treatment guidelines. Strong evidence suggests that neither site nor route of antibiotic administration affects the short or long-term major outcome of women with mild or moderate disease. Data on women with severe disease was inadequate to influence the results of the study. [5]
Prevention
Risk reduction against sexually transmitted diseases through abstinence or barrier methods such as condoms, see human sexual behavior for other listings.
Going to the doctor immediately if symptoms of PID, sexually transmitted diseases appear, or after learning that a current or former sex partner has, or might have had a sexually transmitted disease.
Getting regular gynecological (pelvic) exams with STD testing to screen for symptomless PID.[6]
Discussing sexual history with a trusted physician in order to get properly screened for sexually transmitted diseases.
Regularly scheduling STD testing with a physician and discussing which tests will be performed that session.
Getting a STD history from your current partner and insisting they be tested and treated before intercourse.
Understanding when a partner says that they have been STD tested they usually mean chlamydia and gonorrhea in the US, but that those are not all of the sexually transmissible diseases.
Treating partners to prevent reinfection or spreading the infection to other people.
Other diseases that can lead to or be involved in PID
Salpingitis, any infection of the fallopian tubes.
Tubo-ovarian abscess an abscess of the fallopian tube or ovary.
Endometritis
Pelvic peritonitis
The Dalkon Shield (withdrawn from the market in 1975 for this reason)
Bacterial Vaginosis
References
^ a b c d Loscalzo, Joseph; Andreoli, Thomas E.; Cecil, Russell L.; Carpenter, Charles A.; Griggs, Robert C. (2001). Cecil essentials of medicine. Philadelphia: W.B. Saunders. ISBN 0-7216-8179-4.
^ STD Facts - Pelvic inflammatory disease (PID). Retrieved on 2007-11-23.
^ a b c Lauren Nathan; DeCherney, Alan H.; Pernoll, Martin L. (2003). Current obstetric & gynecologic diagnosis & treatment. New York: Lange Medical Books/McGraw-Hill. ISBN 0-8385-1401-4.
^ Blenning CE, Muench J, Judkins DZ, Roberts KT (2007). "Clinical inquiries. Which tests are most useful for diagnosing PID?". J Fam Pract 56 (3): 216–20. PMID 17343812.
^ Walker CK, Wiesenfeld HC (2007). "Antibiotic therapy for acute pelvic inflammatory disease: the 2006 Centers for Disease Control and Prevention sexually transmitted diseases treatment guidelines". Clin. Infect. Dis. 44 Suppl 3: S111–22. doi:10.1086/511424. PMID 17342664.
^ Smith KJ, Cook RL, Roberts MS (2007). "Time from sexually transmitted infection acquisition to pelvic inflammatory disease development: influence on the cost-effectiveness of different screening intervals". Value Health 10 (5): 358–66. doi:10.1111/j.1524-4733.2007.00189.x. PMID 17888100.
External links
NIH/Medline
CDC
Pelvic Inflammatory Disease (PID; Salpingitis, Endometritis)
Epidemiology
In the United States, more than one million women are affected by PID each year, and the rate is highest with teenagers. Over 100,000 women become infertile in the US each year from PID.[2] N. gonorrhoea is isolated in only 40-60% of women with acute salpingitis.[3] C. trachomatis was estimated by current obgyn 9th ed to be the cause in about 60% of cases of salpingitis, which may lead to PID. It is unsure how much is due to a single organism and how much is due to multiple organisms; many other pathogens that are in normal vaginal flora become involved in PID. 10% of women in one study had asymptomatic Chlamydia trachomatis infection and 65% had asymptomatic infection with Neisseria gonorrhoeae.[3] It was noted in one study that 10-40% of untreated women with N. gonorrhoea develop PID and 20-40% of women infected with C. trachomitis developed PID.[1] PID is the leading cause of infertility. "A single episode of PID results in infertility in 13% of women."[1] This rate of infertility increases with each infection.
Diagnosis
There may be no actual symptoms of PID. If there are symptoms then fever, cervical motion tenderness, lower abdominal pain, new or different discharge, painful intercourse, or irregular menstrual bleeding may be noted. It is important to note that PID can occur and cause serious harm without causing any noticeable symptoms. Laparoscopic identification is helpful in diagnosing tubal disease, 65-90% positive predictive value in patients with presumed PID.[3] Regular Sexually transmitted disease (STD) testing is important for prevention. Treatment is usually started empirically because of the terrible complications. Definitive criteria include: histopathologic evidence of endometritis, thickened filled fallopian tubes, or laparoscopic findings. Gram-stain/smear becomes important in identification of rare and possibly more serious organisms.[1]
Differential diagnosis
Appendicitis, ectopic pregnancy, septic abortion, hemorrhagic or ruptured ovarian cysts or tumors, twisted ovarian cyst, degeneration of a myoma, and acute enteritis must be considered. Pelvic inflammatory disease is more likely to occur when there is a history of pelvic inflammatory disease, recent sexual contact, recent onset of menses, or an IUD in place or if the partner has a sexually transmitted disease.
Acute pelvic inflammatory disease is highly unlikely when recent intercourse has not taken place or an IUD is not being used. A sensitive serum pregnancy test should be obtained to rule out ectopic pregnancy. Culdocentesis will differentiate hemoperitoneum (ruptured ectopic pregnancy or hemorrhagic cyst) from pelvic sepsis (salpingitis, ruptured pelvic abscess, or ruptured appendix).
Pelvic and vaginal ultrasounds are helpful in the differential diagnosis of ectopic pregnancy of over six weeks. Laparoscopy is often utilized to diagnose pelvic inflammatory disease, and it is imperative if the diagnosis is not certain or if the patient has not responded to antibiotic therapy after 48 hours.
No single test has adequate sensitivity and specificity to diagnose pelvic inflammatory disease. A large mulitsite U.S. study found that cervical motion tenderness as a minimum clinical criterion increases the sensitivity of the CDC diagnostic criteria from 83% to 95%. However, even the modified 2002 CDC criteria does not identify women with subclinical disease.[4]
Prognosis
Although the PID infection itself may be cured, effects of the infection may be permanent. This makes early identification by someone who can prescribe appropriate curative treatment so important in the prevention of damage to the reproductive system. Since early gonococcal infection may be asymptomatic, regular screening of individuals at risk for common agents (history of multiple partners, history of any unprotected sex, or people with symptoms) or because of certain procedures (post pelvic operation, postpartum, miscarriage or abortion). Prevention is also very important in maintaining viable reproduction capabilities.
If the initial infection is mostly in the lower tract, after treatment the person may have few difficulties. If the infection is in the fallopian tubes or ovaries, more serious complications are more likely to occur.
Complications
PID can cause scarring inside the reproductive organs, which can later cause serious complications, including chronic pelvic pain, infertility (difficulty becoming pregnant), ectopic pregnancy (the leading cause of pregnancy-related deaths in adult females), and other dangerous complications of pregnancy. Multiple infections and infections that are treated later are more likely to result in complications.
Infertile women may wish to see a specialist, because there may be a possibility in restoring fertility after scarring. Traditionally tuboplastic surgery was the main approach to correct tubal obstruction or adhesion formation, however success rates tended to be very limited. In vitro fertilization (IVF) was developed to bypass tubal problems and has become the main treatment for patients who want to become pregnant.
Treatment
Treatment depends on the cause and generally involves use of antibiotic therapy. If the patient has not improved within two to three days after beginning treatment with the antibiotics, they should return to the hospital for further treatment. Drugs should also be given orally and/or intravaneously to the patient while in the hospital to begin treatment immediately to increase the effectiveness of antibiotic treatment. Hospitalization may be necessary if Tubo-ovarian abscess, very ill, immunodeficient, pregnancy, incompetence, or because this or something else life threatening can not be ruled out. Treating partners for STD's is a very important part of treatment and prevention. Anyone with PID and partners of patients with PID since six months prior to diagnosis should be treated to prevent reinfection. Psychotherapy is highly recommended to women diagnosed with PID as the fear of redeveloping the disease after being cured may exist. It is important for a patient to communicate any issues and/or uncertainties they may have to a doctor, especially a specialist such as a gynecologist, and in doing so, to seek follow-up care.
A systematic review of the literature related to PID treatment was performed prior to the 2006 CDC sexually transmitted diseases treatment guidelines. Strong evidence suggests that neither site nor route of antibiotic administration affects the short or long-term major outcome of women with mild or moderate disease. Data on women with severe disease was inadequate to influence the results of the study. [5]
Prevention
Risk reduction against sexually transmitted diseases through abstinence or barrier methods such as condoms, see human sexual behavior for other listings.
Going to the doctor immediately if symptoms of PID, sexually transmitted diseases appear, or after learning that a current or former sex partner has, or might have had a sexually transmitted disease.
Getting regular gynecological (pelvic) exams with STD testing to screen for symptomless PID.[6]
Discussing sexual history with a trusted physician in order to get properly screened for sexually transmitted diseases.
Regularly scheduling STD testing with a physician and discussing which tests will be performed that session.
Getting a STD history from your current partner and insisting they be tested and treated before intercourse.
Understanding when a partner says that they have been STD tested they usually mean chlamydia and gonorrhea in the US, but that those are not all of the sexually transmissible diseases.
Treating partners to prevent reinfection or spreading the infection to other people.
Other diseases that can lead to or be involved in PID
Salpingitis, any infection of the fallopian tubes.
Tubo-ovarian abscess an abscess of the fallopian tube or ovary.
Endometritis
Pelvic peritonitis
The Dalkon Shield (withdrawn from the market in 1975 for this reason)
Bacterial Vaginosis
References
^ a b c d Loscalzo, Joseph; Andreoli, Thomas E.; Cecil, Russell L.; Carpenter, Charles A.; Griggs, Robert C. (2001). Cecil essentials of medicine. Philadelphia: W.B. Saunders. ISBN 0-7216-8179-4.
^ STD Facts - Pelvic inflammatory disease (PID). Retrieved on 2007-11-23.
^ a b c Lauren Nathan; DeCherney, Alan H.; Pernoll, Martin L. (2003). Current obstetric & gynecologic diagnosis & treatment. New York: Lange Medical Books/McGraw-Hill. ISBN 0-8385-1401-4.
^ Blenning CE, Muench J, Judkins DZ, Roberts KT (2007). "Clinical inquiries. Which tests are most useful for diagnosing PID?". J Fam Pract 56 (3): 216–20. PMID 17343812.
^ Walker CK, Wiesenfeld HC (2007). "Antibiotic therapy for acute pelvic inflammatory disease: the 2006 Centers for Disease Control and Prevention sexually transmitted diseases treatment guidelines". Clin. Infect. Dis. 44 Suppl 3: S111–22. doi:10.1086/511424. PMID 17342664.
^ Smith KJ, Cook RL, Roberts MS (2007). "Time from sexually transmitted infection acquisition to pelvic inflammatory disease development: influence on the cost-effectiveness of different screening intervals". Value Health 10 (5): 358–66. doi:10.1111/j.1524-4733.2007.00189.x. PMID 17888100.
External links
NIH/Medline
CDC
Pelvic Inflammatory Disease (PID; Salpingitis, Endometritis)
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