Kensey Nash, a provider of resorbable biomaterial technology for a wide range of medical procedures, has received FDA 510(k) clearance for its second extracellular matrix (ECM) product, Meso BioMatrix.
The clearance allows Kensey Nash for the use of Meso BioMatrix in general surgery for the reinforcement and repair of soft tissue, including hernia repair, plastic and reconstructive surgery, urologic, gynecologic and gastroenterologic applications.
The Meso BioMatrix product is a porcine-based mesothelium (Meso) extracellular matrix designed to reinforce soft tissues where weakness exists in patients requiring soft tissue repair.
Medeor Matrix, Kensey Nash’s previously cleared dermal matrix product, and the Meso BioMatrix are manufactured using Kensey Nash’s proprietary Optrix process, which gently disinfects tissues, inactivates viruses and removes cells while preserving extracellular matrix components.
Kensey Nash is currently evaluating partnering opportunities for the Meso BioMatrix products in the urogynecology, wound care, orthopaedic and other markets.
Doug Evans, chief operating officer of Kensey Nash, said: “Meso BioMatrix and Medeor Matrix represent two distinct product platforms that put Kensey Nash in the unique position to provide surgeons multiple options with respect to tissue source and handling characteristics when selecting a biologic mesh.
“We expect these efforts to yield new collaborative partners and additional products in the rapidly growing biosurgery market that will provide continued diversification and expansion of our business in the future. As a company, we remain committed to developing unique and effective therapies that address the clinical needs of physicians and patients around the world.”