FDA clears Organogenesis' FortaGen surgical mesh:
This article was originally published in Clinica
Executive Summary
Organogenesis has received US FDA 510(k) clearance to market its bioengineered surgical mesh for use in soft tissue reinforcement applications. FortaGen, which is comprised of the company's FortaFlex bioengineered matrix technology, is a tissue repair product that has been optimised for the strength and tissue interaction requirements of specific surgical applications, says the Canton, Massachusetts firm. Initial target applications for the product include complex/recurrent hernias, ostomy reinforcement, abdominoplasty and muscle flap donor sites. Around 475,000 of these procedures are performed every year in the US.