Mesh Suture, Inc. Achieves Regulatory Milestones for Global Surgical Solutions

Mesh Suture, Inc. Achieves Crucial Regulatory Approvals

Mesh Suture, Inc. (MSi) recently announced significant regulatory milestones for its flagship product, DURAMESH™. This innovative technology is designed to redefine surgical closure standards, ensuring heightened patient safety and efficacy in surgical repairs.

On October 21, 2025, MSi revealed that it has obtained certifications under both the European Union Medical Device Regulation (EU MDR) and the Medical Device Single Audit Program (MDSAP). These certifications are not just regulatory checkmarks; they signify a commitment to delivering a safe, reliable, and effective surgical closure solution. The EU MDR certification guarantees that DURAMESH™ will be available in the European market for years to come, replacing earlier certifications under the Medical Device Directive. Meanwhile, the MDSAP certification validates compliance with regulations in multiple countries, including the United States, Canada, Brazil, and Australia, thus paving the way for MSi to explore new markets beyond the U.S.

DURAMESH™ features an innovative linear mesh structure made from large-pore, non-absorbable polypropylene. This design incorporates forces and tissue integration to create a robust surgical repair that strengthens over time. In clinical comparisons, DURAMESH™ has demonstrated lower early complication rates than traditional suture techniques, affirming its efficacy in diverse surgical applications.

Gregory Dumanian, MSi's Founder and Chief Medical Officer, expressed enthusiasm about the regulatory achievements. "Securing both MDR and MDSAP approvals exemplifies our quality-first approach and ambition to redefine surgical closure standards. Our DURAMESH™ technology provides a more durable, reliable option for surgical repairs. This announcement brings us closer to making these innovations accessible to more surgeons and patients worldwide," he stated.

As of now, DURAMESH™ is in clinical use at over 100 hospitals across the United States and is also available in regions including the UK, EU, Turkey, and Mexico. Mesh Suture, Inc. takes pride in being a surgeon-founded medical device company rooted in extensive clinical research and patient care. The enterprise aims to eliminate one of surgery's most prevalent issues: failed tissue repairs due to suture pull-through, an avoidable complication that can significantly impact patient recovery.

The advancements heralded by MSi through DURAMESH™ not only mark a turning point in surgical repair technology but also contribute to better surgical outcomes and enhanced patient care. The company’s focused approach on innovation and regulatory compliance ensures that it continues to elevate surgical standards globally.

For more information on MSi and its groundbreaking products, please visit meshsuture.com.