ASCOT, England, January 16 /PRNewswire/ --
- Now Approved for Spinal Procedures and Use as Adhesion Barrier
Codman, a Johnson & Johnson company, announced today that its DURAFORM(TM) Dural Graft Implant has been approved for two new uses in Europe. The collagen-based implant is now approved for use in spinal procedures and as an adhesion barrier to prevent peridural fibrosis.
DURAFORM implant was first approved by the British Standards Institution (BSI) in 2004 for procedures where the repair or substitution of the patient's dura mater is required. The additional indications are based on a study that showed equivalency to another dural graft that is already approved for spinal procedures and as an adhesion barrier.
"Now more patients can benefit from DURAFORM implant's unique combination of superior strength, handling and conforming capabilities," said P. Laxminarain, Worldwide President, Codman. "These new indications provide a new choice for neurosurgeons and spine surgeons and should increase the use of DURAFORM implant throughout the European Union."
DURAFORM implant is manufactured using a patent-pending process that allows for better handling characteristics and greater tear resistance than other onlay dural graft materials.
DURAFORM implant is composed of a unique structural matrix that gives it enhanced wet handling capabilities and enhanced anatomical conformity to the contours of the brain. This minimizes undesirable creases and folds to help prevent leakage of cerebrospinal fluid (CSF).
DURAFORM implant is made of collagen-based biocompatible material that exhibits improved tensile strength and wet handling capabilities. The collagen used in its production is obtained from a geographical BSE risk level I source, the lowest risk category available.
DURAFORM implant is contraindicated in patients with known sensitivity to bovine-derived materials.
About Codman
Codman, a Johnson & Johnson company, develops and markets a wide range of diagnostic and therapeutic products for the treatment of central nervous system disorders. The company was founded in 1838 and has established a strong leadership position within the industry.
Distributed by PR Newswire on behalf of Codman
http://www.prnewswire.co.uk/cgi/news/release?id=188160
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