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