Bone Graft Extender and Void Filler Approved for Marketing
The new Plexur P Biocomposite from Osteotech, Incorporated received marketing clearance for additional indications from the Food and Drug Administration. Approval was noted on the PR Newswire. The new indications for the product include use in the spine as a bone graft extender and a bone void filler. It was previously approved to fill voids in the bone of the pelvis and bony extremities.
Plexur P incorporates bone tissue for an array of different surgical procedures. It is comprised of an osteoconductive biocomposite of cortical fibers. Processing of the materials inactivates viruses, such as HIV, CMV, and Hepatitis B and C. The fillers are also terminally sterilized to minimize any potential risk of disease transmission, as described on the company’s website.
Bone tissue is combined with a range of polymers for use in the human and xenograft bone tissue. These materials are suspended in a porous, resorbable scaffold. The system wicks blood in addition to packing easily while simultaneously maintaining the porosity and shape of the filler.
Plexur P is available in cylinders, wedges, sheets, granules, and blocks. The product can be used in combination with other products available from Osteotech. Those include Kinesis BMAC cellular system, Grafton DBM, and local bone.
The company plans to commence marketing this product to surgeons treating diseases of the spine as soon as possible. Osteotech specializes in the development of regenerative medicine solutions to treat musculoskeletal conditions. Therapies are designed to restore function, promote biologic healing, and alleviate pain.
April 29, 2008 Related topics: Product Launches, Product Approval & Certification, Orthopedic