Kips Bay Medical, Inc. (NASDAQ: KIPS) today provides an FDA update and announces financial results for its second quarter ended June 30, 2012.
As previously announced on July 18, 2012, Kips Bay Medical filed an application for an Investigational Device Exemption (“IDE”) with the U.S. Food & Drug Administration (“FDA”) to include four U.S. sites in the “eMESH I” clinical feasibility study of its innovative eSVS
Mesh device currently being pursued in Europe. As of the date of this press release, a number of leading cardiac centers in the U.S. have already expressed an interest in participating in the eMESH I study, pending FDA approval of the IDE.
The eSVS Mesh is a highly flexible, kink-resistant tubular prosthesis made of knitted nitinol wire. It fits externally over the saphenous vein and is designed to provide strength and support for maintaining graft patency.
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.
In Europe, Kips Bay Medical continues to work through the ethics committee review and approval process at its selected clinical study sites. Two sites have received ethics committee approval and are in the process of finalizing clinical study agreements.
Kips Bay Medical intends to enroll up to 120 patients in the eMESH I study, with a primary efficacy endpoint of graft patency, or openness, at twelve months. This feasibility trial is designed to provide information required by the FDA to support the approval of an investigational device exemption (“IDE”) for a larger pivotal study. A pivotal study is required to demonstrate clinical safety and efficacy in support of a request for an approval to sell our eSVS Mesh in the U.S.