Mesh Suture, Inc. Achieves Regulatory Milestones for DURAMESH™, Revolutionizing Surgical Repairs Worldwide

Mesh Suture, Inc. Advances Surgical Solutions with DURAMESH™ Certifications

Introduction

Mesh Suture, Inc. (MSi) has made significant strides in the realm of surgical closure technology. With recent achievements of essential regulatory certifications, the company is set to change the dynamics of surgical repairs through its flagship product, DURAMESH™. This advancement underscores MSi's commitment to enhancing patient outcomes globally.

Regulatory Milestones

On October 21, 2025, MSi announced that it has successfully achieved two crucial regulatory certifications. The first is through the European Union Medical Device Regulation (EU MDR), assuring that DURAMESH™ is compliant with the latest safety standards for the European market. This approval replaces the previous Medical Device Directive certification, ensuring the product's continuous availability in Europe for the foreseeable future.

Additionally, MSi has received the Medical Device Single Audit Program (MDSAP) certification. This allows the company to comply with regulations across multiple countries including the United States, Canada, Brazil, and Australia. Such certifications significantly broaden MSi's potential market reach, paving the way for innovative surgical solutions to be more widely adopted around the globe.

Innovative Technology Behind DURAMESH™

DURAMESH™ utilizes a cutting-edge linear mesh structure, engineered from large-pore non-absorbable polypropylene. This proprietary technology enhances force distribution and promotes tissue integration, resulting in a robust surgical repair system that improves in performance over time. Compared to traditional sutures, DURAMESH™ has demonstrated lower early complication rates, making it a preferable choice for surgeons. [1][2]

Gregory Dumanian, MSi’s Founder and Chief Medical Officer, expressed enthusiasm about the certifications, stating, “We are thrilled to have secured both MDR and MDSAP approvals, a testament to our quality-first approach and global ambition.” His insights reflect the company’s dedication to addressing common surgical challenges effectively.

Global Reach and Clinical Use

Currently, DURAMESH™ is in active clinical use in over 100 hospitals across the United States. Additionally, the product is now available in several international markets, including the UK, EU, Turkey, and Mexico. The global accessibility of DURAMESH™ not only benefits surgeons but also patients in need of surgical repairs across varied medical scenarios.

About Mesh Suture, Inc.

Founded by surgeons and rooted in extensive clinical research and patient care, Mesh Suture, Inc. aims to revolutionize surgical wound closure practices. The company emerged from innovative studies conducted at Northwestern University's Feinberg School of Medicine in Chicago, IL, focusing primarily on abdominal wall reconstruction and hand tendon surgery.

The core mission of MSi is to eliminate one of the most prevalent issues in surgical procedures: failed tissue repairs due to suture pull-through. With a focus on innovative solutions, the company is committed to addressing such problems effectively and safely.

Conclusion

With the recent certifications achieved for DURAMESH™, Mesh Suture, Inc. is setting a new benchmark in the surgical repair industry. By prioritizing safety and efficacy, MSi not only uplifts surgical practices but also enhances the overall quality of patient care. As the company moves forward, it remains focused on providing innovative solutions that could reshape the future of surgical closures.

References:
1. Perez, M. M., et al. (2025). "Outcomes Following Implantation With Mesh Suture A Registry of 1111 Patients." Plastic Reconstructive Surgery-Global Open.
2. Shapiro, M., et al. (2024). "DURAMESH registry study short-term outcomes using mesh suture for abdominal wall closure." Front Surgery.