Kips Bay Medical on Tuesday announced the first implant in the United States as part of its eMESH I clinical feasibility trial. The eMESH trial will collect patient data on the performance of Kips Bay’s eSVS Mesh, which is designed to strengthen veins used in coronary bypass graft surgery and keep the grafted vessel from closing.
The first U.S. implant was performed at the Northeast Georgia heart Center in Gainesville, Ga., by Dr. J. Alan Wolfe.
“Our first implant of the eSVS Mesh graft went very smoothly and the patient is doing well and recovering normally. I am very impressed by the ease of use and excellent handling characteristics of the eSVS Mesh.” Wolfe said. “Bypass graft closure is the most significant problem that we find in patients with atherosclerotic disease. The eSVS Mesh device is designed to prevent saphenous vein grafts from closing. I believe that it holds the potential to favorably impact the patient’s quality of life and reduce the need for future, costly coronary re-interventions.”
Kips Bay CEO Manny Villafana said: “We are excited to begin clinical study of our eSVS Mesh here in the United States. This first U.S. implant represents another significant milestone in the development of our eSVS Mesh technology for coronary artery bypass surgery.”
The eMESH I trial is a multi-center, randomized study designed to demonstrate the initial safety and performance of the eSVS Mesh for use as an external saphenous vein graft support device during coronary artery bypass graft (CABG) surger. Kips Bay officials said they expect to enroll up to 120 patients at eight European and four U.S. sites. They hope to use the data from this study as the basis for later requesting a pivotal trial in the United States.
Kips Bay Medical was founded in 2007 and is headquartered in Minneapolis. Its eSVS mesh is a metal mesh sleeve that, when placed on the outside of a saphenous vein graft during CABG surgery, is designed to improve the structure and long-term performance of the graft.