FDA 510(k) clearance for new drug-embedded mesh

Ariste Medical, a pre-commercial drug+device company, has received 510(k) clearance (#K211132) from the U.S. Food and Drug Administration (FDA) to market its drug-embedded, synthetic hernia mesh in the United States. The new mesh aims to reduce the risk of microbial colonization during surgical implantation.

The FDA 510(k) clearance represents 15 years of dedicated research, during which Ariste has been awarded 18 patents and proprietary formulations positioning it as a flexible technology capable of delivering novel drug+device combinations to address clinical complications where infection, inflammation or clotting are ongoing challenges associated with implantable surgical devices.

With more than 400,000 procedures performed annually, ventral hernia repair is among the most common surgeries in the United States, but often results in high rates of infection which can lead to excess morbidity and healthcare expenses. Mesh-related infection following surgical repair of ventral hernia can range from 8% to 40%, depending on patient risk factors and the complexity of the surgical case. Ariste’s patented formulation enables a polypropylene mesh to carry the proven antibiotics minocycline and rifampin to prevent mesh contamination by bacterial pathogens associated with surgical site infections, such as MRSA and E. coli. The formulation can be applied to a variety of medical devices and can incorporate any drug so that drug+device combinations can address infection, restenosis, thrombosis, and inflammation.

20220330_Ariste_Teaser_V03 from POPi/o Video Banking on Vimeo.

“Regulatory clearance of the Ariste antibiotic embedded mesh is an important milestone toward reducing incidence of implant bacterial colonization in open ventral hernia repair,” says 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.”

“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,” says 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. “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.”