FDA Approves Kips Bay Medical Trial Expansion

The U.S. Food and Drug Administration (FDA) has approved Minneapolis, Minn.-based Kips Bay Medical Inc. to include more U.S. patients and U.S. study sites in its eMESH I clinical feasibility trial for its eSVS Mesh.

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, Kips Bay 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 strength while remaining highly flexible and kink-resistant.

The saphenous vein is the large, subcutaneous, superficial vein of the leg.

In its initial approval, the FDA indicated that it would allow a staged enrollment within the United States, starting with 15 patients at up to four sites in the United States. The FDA has now increased the approved number of U.S. patients from 15 to 27 (15 additional from the 12 enrolled to date) and increased the allowed number of U.S. sites from four to 10.

In addition, the FDA has also approved a combination of changes in the application of the eSVS Mesh to the saphenous vein graft and to the surgical implant technique for the eSVS Mesh treated graft. The changes are intended to reduce the risk of early graft occlusion, make it easier to implant the eSVS Mesh and reduce procedural costs.

“We are very pleased with this expanded approval which allows the Cleveland Clinic, the Lenox Hill Hospital and other interested U.S. sites to become active and commence enrolling patients in our eMESH I clinical feasibility trial,” said Manny Villafanya, founder, chairman and CEO of Kips Bay. “I am grateful for the perseverance of our team here at Kips Bay and their dedication to bringing the eSVS Mesh forward through the U.S. regulatory process.”

The eMESH I clinical feasibility trial is a multi-center, randomized study of external saphenous vein support using Kips Bay Medical’s eSVS Mesh in coronary artery bypass (CABG) surgery. The objective of this study is to demonstrate the initial safety and performance of the eSVS Mesh for use as an external SVG support device during CABG surgery. The company intends to work with its European and U.S. sites to use its newly approved implant technique on all patients going forward and further expects to use the data from this study as the basis for requesting an investigational device exemption to conduct a larger pivotal trial in the United States.

Kips Bay Medical makes saphenous vein support technology for use in coronary artery bypass grafting surgery. Kips Bay originally acquired the eSVS Mesh technology from Medtronic Inc. in 2007.