Ariste Medical Gets FDA’s 510(k) Clearance for Antimicrobial Mesh for Hernia Repair

Salt Lake City, Utah-based Ariste Medical has received the FDA’s 510(k) clearance for its drug-embedded, synthetic hernia mesh, which is designed to lower the risk of microbial colonization during mesh implantation.

Infection following open hernia repair “continues to be a challenge that leads to a vicious cycle of reoperations, negatively impacting patients' quality of life," said Michael Rosen, a surgeon at the Cleveland Clinic who is also an Ariste board member.

The Ariste mesh helps reduce bacterial colonization in and around the mesh implant, and prevents infections, leading to “better long-term patient outcomes and reduced costs of care," Rosen said.