Cardiac surgeons at a New Jersey Hospital have performed the first implant of the eSVS mesh implant made by Kips Bay Medical. This implant was performed as part of the Kips Bay Medical eMESH I clinical feasibility trial currently being conducted for the U.S. Food and Drug Administration (FDA) in a number of cardiac surgery centers in both Europe and the United States. The procedure took place at The Valley Hospital Heart and Vascular Institute in Ridgewood, N.J.

The eSVS Mesh is designed to be fitted like a sleeve on the outside of saphenous vein grafts (SVGs) to strengthen SVGs used in coronary artery bypass graft surgery. By strengthening the SVG and preventing the damaging expansion of the vein graft, the company hopes to reduce or prevent the resulting injury which can lead to SVG failure and potentially costly and complicated re-interventions for patients undergoing CABG surgery. The eSVS Mesh is manufactured from nitinol wire for strength, flexibility and kink-resistance.

The procedure was performed by Alex Zapolanski, M.D., director of cardiac surgery at The Valley Hospital and clinical professor of surgery, Columbia University College of Physicians and Surgeons; and Juan B. Grau, M.D., director of cardiac translational research at The Valley Hospital and associate professor of surgery, Columbia University College of Physicians and Surgeons and site principal investigator; at the Valley Hospital Heart and Vascular Institute.

“After completing my first case, I found the eSVS Mesh to be remarkably easy to implant and feel very comfortable with the device,” said Zapolanski. “I am pleased that we are able to be part of the eMESH I trial and it is my hope that this device will open the door to improved long-term outcomes for coronary artery bypass grafting surgery patients.”

The eMESH I clinical feasibility trial is a multi-center, randomized study of external saphenous vein graft (SVG) support using Kips Bay Medical’s eSVS Mesh in coronary artery bypass grafting (CABG) surgery. The objective of the trial is to demonstrate to the FDA the initial safety and performance of the eSVS Mesh for use as an external SVG support device during CABG surgery. If the trial is successful, the company intends to use the data from this study as the basis for the filing of a request for an investigational device exemption, or IDE, to perform a larger pivotal study.

Based in, Minneapolis, Minn.-based Kips Bay Medical is focused on external saphenous vein support technology.