Kips Bay Medical Announces the First eSVS Mesh Implant by the Mayo Clinic
Manny Villafaña, Chairman and CEO of Kips Bay Medical, Inc. (NASDAQ:KIPS) announced that on April 30, 2013, the Mayo Clinic performed its first implant of an eSVS® Mesh at its Rochester, Minnesota facility. 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.
“We are honored to have such a prestigious center as the Mayo Clinic participating in our eMESH I trial.”
Mr. Villafaña stated “We are honored to have such a prestigious center as the Mayo Clinic participating in our eMESH I trial.”
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 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.
About Kips Bay Medical
Kips Bay Medical, Inc., founded in 2007 and headquartered in Minneapolis, Minnesota, is a medical device company focused on manufacturing and commercializing its external saphenous vein support technology, or eSVS MESH, for use in coronary artery bypass grafting surgery. The eSVS MESH is a nitinol mesh sleeve that, when placed on the outside of a saphenous vein graft during CABG surgery, is designed to improve the structural characteristics and long-term performance of the saphenous vein graft. Additional information about Kips Bay Medical, Inc. can be found at www.KipsBayMedical.com .