Kips Bay Medical’s First Vein Graft Mesh Implantation a Success

Kips Bay Medical Inc., a Minneapolis, Minn.-based maker of external saphenous vein (the large, subcutaneous vein in the leg) support technology, has seen the first implantation of its eSVS mesh. The implantation procedure was performed at the Emory Heart & Vascular Center in Atlanta, Ga., as part of the company’s 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 eSVS mesh is designed to be fitted like a sleeve on the outside of saphenous vein grafts (SVG) 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. To strengthen an SVG, the eSVS mesh is manufactured from nitinol wire, which gives the eSVS mesh considerable strength, while remaining highly flexible and kink-resistant.

The first implantation procedure was performed by Professor John D. Puskas, M.D., who is a principal investigator for the eMESH I clinical feasibility trial and founder of the Cardiothoracic Clinical Research Unit at the Emory Heart & Vascular Center.

“We are excited to be enrolling patients in the eMESH I clinical feasibility study,” said Puskas. “There is a great need to improve long term patency of saphenous vein grafts used in coronary artery bypass surgery and the eSVS mesh may be a tool to help accomplish that.”

The eMESH I clinical feasibility trial is a multi-center, randomized study of external saphenous vein support using Kips Bay’s eSVS mesh in coronary artery bypass graft (CABG) surgery. The objective of this study is to demonstrate the initial safety and performance of the eSVS mesh for use as an external saphenous vein graft support device during CABG surgery. Kips Bay Medical expects to enroll up to 120 patients at eight European and four U.S. sites, and expects to use the data from this study as the basis for the filing of a request for an investigational device exemption (IDE) to perform a pivotal trial in the United States.