Mesh Suture, Inc. Secures Key Regulatory Approvals, Accelerating Global Access to DURAMESH™ for Surgeons Worldwide

CHICAGO, Oct. 21, 2025 /PRNewswire/ -- 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

Sign up for Blog Updates