FDA Clears Antibiotic-Embedded Hernia Mesh

Ariste Medical announced that its antiobiotic-embedded hernia mesh received 510(k) clearance to market in the US by the US Food and Drug Administration (FDA). The company has garnered 18 patents and proprietary formulations over 15 years to bring its biotechnology to this point.

Ventral hernia repair is frequently performed in the US, with more than 400K procedures each year. Following the surgery, infection occurs 8-40% of the time which leads to a pattern of reoperations.

By limiting the risk of microbial colonization with this new mesh, the amount of reoperations and healthcare costs can also be reduced. The mesh works by administering targeted agents to eliminate bacteria like MRSA and E. coli.

“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,” Michael Rosen, MD, Director, Abdominal Core Health, Cleveland Clinic Center, Board member, Ariste, Medical Director of the nationwide Abdominal Core Health Quality Collaborative said in a statement.

“Yet—infections are preventable," he continued. "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.”

Additionally, the mesh functions as a protective platform to mitigate the failure of other implants. Its formulation can be applied to a variety of medical devices. The drug utilized within the device can also be altered based on the procedure or treatment protocol. The versatility of the drug and device combination can address infection, restenosis, thrombosis, and inflammation.