Kips Bay Medical, Inc. (NASDAQ:KIPS) along with Manny Villafaña, its Founder, Chairman and CEO, announced today that Kips Bay Medical has filed an application for an Investigational Device Exemption (“IDE”) with the U.S. Food & Drug Administration (“FDA”) to include four U.S. sites in its “eMESH I” clinical feasibility study of its eSVS
Mesh device currently being pursued in Europe.
Kips Bay Medical submitted this IDE application based upon the FDA’s response to its April 2012 Pre-IDE submission in which Kips Bay provided additional information to the FDA on the performance of its eSVS Mesh. The FDA advised Kips Bay Medical that it was allowed to proceed with this filing for an IDE.
As previously announced, Kips Bay Medical has been pursuing a feasibility trial at eight well known cardiac centers throughout Germany, Switzerland, Italy and France. This European trial is a multi-center, prospective, randomized study of external saphenous vein graft support using its eSVS Mesh in coronary artery bypass grafting (“CABG”) surgery and is titled the "eMESH I" study. If Kips Bay Medical receives approval of this application for an IDE, it intends to expand the eMESH I study to include four of the leading heart hospitals in the United States. The FDA has 30 days to respond to an IDE application.
The objective of this study is to demonstrate the initial safety and performance of the Kips Bay Medical eSVS Mesh sufficient to allow the FDA to approve an IDE for a pivotal study. Kips Bay Medical is currently working through the ethics committee review and approval process at a select group of European study sites. Kips Bay Medical intends to enroll up to 120 patients at eight European and four U.S. cardiac centers, with a primary efficacy endpoint of graft patency, or openness, at twelve months after CABG surgery. Hands-on surgical training with the eSVS Mesh for physicians at several study sites in Europe has already commenced.