FDA OK’s Ariste’s Antomicrobial Mesh for Hernia Repair

Pre-commercial drug and device company Ariste Medical earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its drug-embedded, synthetic hernia mesh to reduce risk of microbial colonization during 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, and increasing the economic burden of health care and driving up costs for health systems,” Dr. Michael Rosen, Director of Cleveland Clinic Center for Abdominal Core Health, a Board member at Ariste, and Medical Director of the nationwide Abdominal Core Health Quality Collaborative told the press. “Yet—infections are preventable. The Ariste mesh provides surgeons with a cutting-edge tool for reducing bacterial colonization in and around the mesh implant; and preventing infections will lead to better long-term patient outcomes and reduced costs of care.”
 
Ventral hernia repair is among the most common surgeries in the U.S. but often has high rates of infection—it can range from 8-40% depending on risk factors and surgical complexity. Ariste’s formulation lets the polypropylene mesh carry antibiotics minocycline and rifampin to prevent mesh contamination. The formulation can be used on a variety of medical devices and incorporate any drug, potentially addressing infection, restenosis, thrombosis, and inflammation.
 
“Regulatory clearance of the Ariste antibiotic embedded mesh is an important milestone toward reducing incidence of implant bacterial colonization in open ventral hernia repair,” said Dr. Lisa Jennings, co-founder of Ariste. “This achievement comes at a time when there is a greater focus and concern on implant integrity due to healthcare-associated infections. Our patented, novel technology serves as a platform for mitigating failure of other implants due to bacteria burden, as well as for targeting complications due to restenosis or acute thrombosis.”