Kips Bay Medical, Inc. has gained U.S. FDA’s thumbs-up for an expansion of its “eMESH I” clinical feasibility trial of its eSVS® Mesh to include more U.S. patients and U.S. study sites.
You may not have heard of either Kips Bay Medical or its eSVS Mesh, but the story goes that the company was formed and acquired this technology from Medtronic back in 2007. Indeed we covered a news release from the company as recently as last September, here. A quick look at the company’s stock price in the intervening years since its foundation suggests it could do with all the good news it can get, the stock currently trading at a greater than 90% decline from the heady days of a few optimistic years ago.
The eSVS Mesh is designed to be fitted like a sleeve on the outside of saphenous vein graft (SVG) explants to strengthen them for use in coronary artery bypass graft surgery. By strengthening the SVG and preventing the damaging expansion of the vein graft, Kips Bay says it hopes to reduce or prevent injury which can lead to graft failure and potentially costly and complicated re-interventions for patients undergoing CABG surgery.
eSVS Mesh is manufactured from nitinol wire which gives the eSVS Mesh considerable strength, while remaining highly flexible and kink-resistant. It’s like a stent, but on the outside of the vessel, so acts like a restraint.
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.
Data from this study will be used as the basis for an Investigational Device Exemption to conduct a larger pivotal trial in the U.S.
In its initial approval, the FDA indicated that it would allow a staged enrollment within the U.S., starting with 15 patients at up to four sites. This has now been increased to allow inclusion of 27 patients (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,” commented Manny Villafaña, 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.”
Source: Kips Bay Medical, Inc., Globe Newswire