FDA clears Organogenesis' FortaFlex:
This article was originally published in Clinica
Executive Summary
Organogenesis has received US FDA 510(k) marketing clearance for its bioengineered tissue support product. The FortaFlex surgical sling (FortaPerm) is a collagen biomaterial for providing long-term structural support to soft tissue where the patient's own tissue is absent or inadequate. Potential applications for the product include the treatment of urinary incontinence, vaginal prolapse and various reconstructive and aesthetic plastic surgery procedures, says the Canton, Massachusetts firm.