Friday, February 27, 2009
Silk-Based Synthetic Surgical Scaffold Gets FDA Approval
Filed under: Plastic Surgery
Serica Technologies, Inc. out of Medford, Massachusetts has received FDA approval for the SeriScaffold™, the company's long term bioresorbable surgical mesh made out of a proprietary silk-based material.
The press release says that for now the company is aiming its product primarily at plastic and reconstructive surgery market, but other procedures, including rotator cuff and hernia repair surgeries, could benefit from this material:
The SeriScaffold platform technology has the potential to provide a new solution as an off-the-shelf, long-term bioresorbable scaffold for support and repair of weakened or damaged connective tissue. Most notably, SeriScaffold could be used as a sophisticated tissue repair scaffold for the approximately 60,000 women who, according to the American Society of Plastic Surgeons, annually undergo reconstructive procedures resulting from illnesses such as breast cancer.“Major challenges still exist for both surgeons and patients faced with breast reconstruction and other forms of plastic and reconstructive surgery,” said John E. Gross, MD, FACS, Associate Professor of Surgery at the University of Southern California (USC/Keck) School of Medicine and a prominent practicing plastic surgeon in Greater Los Angeles. “For example, in many types of breast surgeries, either following mastectomy, mastopexy (breast lift) or body contouring procedures, there is a significant need for scaffolding technology that can immediately support a geometrically complex implantation site at the time of surgery, and provide the body both the time and structure necessary for optimal healing. A silk-based scaffold that supports immediate tissue
infiltration and maintains its integrity over a longer term, as it is being bioresorbed by the body, may be significant in addressing these clinical needs.”In pre-clinical studies, Serica’s silk-based products are shown to be bioresorbed at slower rates than other common structural proteins, such as collagen, as well as other water soluble synthetic polymers, to enable optimal healing. Serica’s silk-based biomaterials require no re-hydration or advance preparation for surgical implantation.
Press release: Serica Technologies Receives FDA 510(k) Clearance for SeriScaffold™ Technology for Soft Tissue Repair
Product page: SeriScaffold ...
Relevant article abstract: The Use of Long-term Bioresorbable Scaffolds for Anterior Cruciate Ligament Repair
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