Manny Villafaña, Chairman and CEO of Kips Bay Medical Inc. (NASDAQ:KIPS) announced that on August 31, 2012, the first patient was enrolled in the Kips Bay Medical eMESH I clinical feasibility trial at the Bern University Hospital, Bern, Switzerland, by Lars Englberger, MD, Senior Consultant Cardiac Surgeon who stated, “The patient had a smooth and uneventful implant of an eSVS ® Mesh graft and is doing very well after quadruple bypass surgery. I am looking forward to the results of this well-designed, randomized, multicenter study of the eSVS Mesh.” Dr. Englberger further commented, “I think that the eSVS Mesh® will be a very valuable tool to increase mid- and long-term patency of saphenous vein grafts, further improving clinical outcomes of patients undergoing CABG surgery by lowering the need for coronary re-interventions.”
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 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 coronary artery bypass (“CABG”) procedures sufficient to allow the FDA to approve an IDE for a pivotal study in the U.S. The Company expects to enroll up to 120 patients at eight European sites.
Kips Bay Medical continues to pursue an approval from the U.S. FDA to include four U.S. hospitals in the eMESH I clinical feasibility trial. As previously announced, the Company is gathering additional information on the preclinical design testing of the eSVS Mesh requested by the FDA and will provide this information to the FDA in a soon-to-be filed amended IDE Application. If the FDA approves the amended IDE Application, U.S. physicians will then be allowed to begin enrolling patients. Kips Bay Medical has already contacted prominent U.S. heart centers that are taking steps to secure the internal approvals of their institutional review boards and administrations to participate in the study.