Kensey Nash has attained a number of significant milestones for its Meso BioMatrix surgical mesh, which has included the product’s first clinical implantation.
This BioMatrix material can be implanted to strengthen soft tissue in weak patients, who need plastic reinforcement, soft tissue repair and reconstructive surgery.
Dennis Hammond, Partners in Plastic Surgery in Grand Rapids located in Michigan carried out this procedure. He stated that the Meso BioMatrix product provides several benefits for reconstructive and plastic surgery, by strengthening with a precise amount of softness, and re-draping around complex contours and corners. This biomaterial is very useful for reconstructive surgery and plastic reinforcement, he added.
The company will showcase the Meso BioMatrix product at the American Society of Aesthetic Plastic Surgery Meeting in British Columbia, from 5 to 7 May, 2012.
Optrix method from Kensey Nash is used in the manufacturing of the Meso BioMatrix surgical mesh. It makes the tissue germ-free removes cells and inactivates viruses, while protecting extracellular matrix (ECM) parts. This unique tissue is obtained from porcine peritoneum. Fast cellular infiltration is revealed through the pre-clinical studies, comparing to dermis-based xenograft materials.
Kensey Nash’s Meso BioMatrix Wound Matrix has obtained 510k clearance, which enables the application of the Meso BioMatrix device in topical wounds. The company may submit for CE Mark approval for breast and wound surgery applications, and will commence an Investigational Device Exemption (IDE) feasibility clinical study in order to utilize the Meso BioMatrix biomaterial in the reinforcement of soft tissue. FDA has given conditional approval for Kensey Nash on the IDE protocol.