FDA clears Kensey Nash matrix tech
This article was originally published in Clinica
Executive Summary
Kensey Nash has received US 510(k) clearance for its second extracellular matrix (ECM), the Meso BioMatrix. The approval allows the porcine-based mesothelium ECM to be used in general surgery for the reinforcement and repair of soft tissue, including hernia repair, plastic and reconstructive surgery and urologic, gynaecologic and gastroenterological procedures. Exton, Pennsylvania-based Kensey Nash said that it is currently seeking partners to take the Meso BioMatrix into the urogynaecology, wound care and orthopaedic markets. The company’s first ECM was the Medeor product, a dermal matrix which received FDA 510(k) approval in November 2009.