Manny Villafaña, Chairman and CEO of Kips Bay Medical Inc. (NASDAQ:KIPS) announced that on February 5, 2013, the first U.S. patient was implanted with the eSVS
Mesh at the Northeast Georgia Heart Center in Gainesville, Georgia. This implant was performed as part of the Kips Bay Medical eMESH I clinical feasibility trial currently being conducted for the U.S. FDA in a number of preeminent cardiac surgery centers in both Europe and the United States. The procedure was performed by J. Alan Wolfe, MD who stated, “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.” Dr. Wolfe further commented, “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.”
Mr. Villafaña added “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 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 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 (“SVG”) support device during CABG surgery. The Company expects to enroll up to 120 patients at eight European and four U.S. sites and further expects to use the data from this study as the basis for the filing of a request for an investigational device exemption to perform a pivotal trial in the United States.