Mesh Suture, Inc. Secures MDR and MDSAP

Company’s innovative mesh suture technology meets current MDR & MDSAP standards for safety & compliance  

Mesh Suture, Inc. (MSi), a company focused on redefining the standard for surgical closure, today announced it has achieved two major regulatory milestones for DURAMESH^™,  its flagship product for surgical repairs. Notably, MSi has obtained certifications  under both the European Union Medical Device Regulation (EU MDR) and the Medical Device Single Audit Program (MDSAP), reflecting the company’s continued commitment to delivering safe and effective surgical closure solutions globally.

The MDR certification, under the EU’s latest regulatory framework, ensures that DURAMESH^™ will remain available throughout the European market for years to come, replacing the company’s existing certification under the previous Medical Device Directive. Additionally, the MDSAP certification confirms that MSi complies with regulatory frameworks in the United States, Canada, Brazil, and Australia, offering the potential to expand commercial pathways to new markets beyond the US.

Featuring an innovative linear mesh structure, the proprietary large-pore non-absorbable polypropylene technology leverages force distribution and tissue integration to provide a durable surgical repair that strengthens over time. DURAMESH^™ can be used across a wide variety of surgical applications and is validated in numerous peer-reviewed publications, demonstrating lower early complication rates compared to standard sutures.^1,2

“We are thrilled to have secured both MDR and MDSAP approvals, a testament to our quality-first approach and global ambition to redefine the standard for surgical closure,” said Gregory Dumanian, MSi’s Founder and Chief Medical Officer. “Our first-of-its-kind DURAMESH^™ technology provides a more durable and reliable solution for surgical repairs. Today’s announcement brings us closer to delivering that innovation to more patients and surgeons around the world.”

DURAMESH^™ is currently in clinical use at over 100 hospitals throughout the U.S., and is also available in the UK, EU, Turkey, and Mexico.

About Mesh Suture, Inc.

Mesh Suture, Inc. is a surgeon-founded medical device company born of decades of clinical research and patient care in both abdominal wall reconstruction and hand tendon surgery at Northwestern University’s Feinberg School of Medicine in Chicago, IL. The company’s singular focus is to eliminate one of surgery’s most common, yet avoidable problems, failed tissue repairs consequent to suture pull-through. To learn more, visit meshsuture.com/.