{"id":48870,"date":"2022-09-27T17:02:30","date_gmt":"2022-09-27T15:02:30","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/mesh-suture-inc-receives-fda-510k-clearance-for-duramesh\/"},"modified":"2022-09-27T17:02:30","modified_gmt":"2022-09-27T15:02:30","slug":"mesh-suture-inc-receives-fda-510k-clearance-for-duramesh","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/mesh-suture-inc-receives-fda-510k-clearance-for-duramesh\/","title":{"rendered":"Mesh Suture, Inc. Receives FDA 510(k) Clearance for DURAMESH\u2122"},"content":{"rendered":"
\n

CHICAGO–(BUSINESS WIRE)–#duramesh<\/a>—Mesh Suture, Inc.<\/a>, d.b.a. MSi, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for DURA<\/b>MESH\u2122 non-absorbable polypropylene mesh suture, a pioneering medical device for the surgical closure of soft tissues including muscles, fascia, tendons, and ligaments.\n<\/p>\n

<\/a>
<\/a><\/p>\n

\nDURA<\/b>MESH\u2122 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.\n<\/p>\n

\nDURA<\/b>MESH\u2122 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. DURA<\/b>MESH\u2122\u2019s novel architecture flattens at the suture-tissue interface to resist pull-through. DURA<\/b>MESH\u2122\u2019s open-walled hollow design also allows tissue ingrowth for implant incorporation with no capsule formation. In a porcine study, DURA<\/b>MESH\u2122 had numerically fewer loose sutures and hernias in comparison to conventional suture.1<\/sup>\n<\/p>\n

\n\u201cDURA<\/b>MESH\u2122 offers the perfect combination of strength and simplicity in a surgical repair,\u201d says Dr. Gregory Dumanian, Chief Medical Officer at MSi. \u201cIt 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 DURA<\/b>MESH\u2122 to address the surgical complication of suture pull-through, we expect to see sizeable improvements in patient outcomes.\u201d\n<\/p>\n

\nDURA<\/b>MESH\u2122 is already in clinical use in the EU and UK, having achieved CE Mark designation in the second quarter of 2021. For more information on DURA<\/b>MESH\u2122 visit meshsuture.com<\/a>.\n<\/p>\n

\nAbout<\/b>\n<\/p>\n

\nMSi (meshsuture.com<\/a>) is a physician-led company born of decades of clinical research and patient care in both abdominal wall reconstruction and hand tendon surgery at Northwestern University\u2019s Feinberg School of Medicine in Chicago, IL. MSi is the ISO 13485:2016 certified manufacturer of the world\u2019s first and only mesh suture. DURA<\/b>MESH\u2122 is the first offering by MSi.\n<\/p>\n

\nDURA<\/b>MESH\u2122 is a trademark of Mesh Suture, Inc. \u00a9 Mesh Suture, Inc. 2019\n<\/p>\n

\nReferences<\/b>\n<\/p>\n

\n1<\/sup> 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.\n<\/p>\n

Contacts<\/b> <\/p>\n

\nMedia Inquiries<\/b>
Adom Dumanian
\n
1-800-298-5468
\n
info@meshsuture.com<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

CHICAGO–(BUSINESS WIRE)–#duramesh—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\u2122 non-absorbable polypropylene mesh suture, a pioneering medical device for the surgical closure of soft tissues including muscles, fascia, tendons, and ligaments. DURAMESH\u2122 is a first-of-its-kind medical device, combining the desirable principle … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-48870","6":"format-standard","7":"category-industry"},"yoast_head":"\nMesh Suture, Inc. 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