DURAMESH™ is already in clinical use in the EU and UK, having achieved CE Mark designation in the second quarter of 2021.
MSi receives FDA Clearance for DURAMESH, the world’s first and only mesh suture (Credit: MSi)
Mesh Suture, Inc., d.b.a. MSi, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for DURAMESH™ non-absorbable polypropylene mesh suture, a pioneering medical device for the surgical closure of soft tissues including muscles, fascia, tendons, and ligaments.
DURAMESH™ is a first-of-its-kind medical device, combining the desirable principle of implant incorporation in a mesh repair with the placement precision of a suture for soft tissue repairs.
DURAMESH™ aims to mitigate the intractable problem of surgical failure due to suture pull-through. The sharp leading edge of a conventional suture can slice through otherwise intact tissue, potentially leading to dehiscence, hernia formation, and poor tendon function. DURAMESH™’s novel architecture flattens at the suture-tissue interface to resist pull-through. DURAMESH™’s open-walled hollow design also allows tissue ingrowth for implant incorporation with no capsule formation. In a porcine study, DURAMESH™ had numerically fewer loose sutures and hernias in comparison to conventional suture.1
“DURAMESH™ offers the perfect combination of strength and simplicity in a surgical repair,” says Dr. Gregory Dumanian, Chief Medical Officer at MSi. “It combines the handling characteristics of traditional suture with a mesh polyfilament design. We are excited to bring this innovative technology to our surgeon colleagues and to their patients who need it most. By designing DURAMESH™ to address the surgical complication of suture pull-through, we expect to see sizeable improvements in patient outcomes.”
Source: Company Press Release