Mesh Suture Inc., d.b.a. MSi, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for DURAMESH non-absorbable polypropylene mesh suture, a 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.”
DURAMESH is already in clinical use in the EU and UK, having achieved CE Mark designation in the second quarter of 2021.
For more information, visit meshsuture.com.
[1] Dumanian GA. Suturable Mesh Demonstrates Improved Outcomes over Standard Suture in a Porcine Laparotomy Closure Model. Plast Reconstr Surg Glob Open. 2021 Oct 15;9(10):e3879. doi: 10.1097/GOX.0000000000003879. PMID: 34667699; PMCID: PMC8519206.
