Kips Bay Medical, Inc. (NASDAQ:KIPS) along with Manny Villafaña, its Founder, Chairman and CEO, announced today that its U.S. feasibility trial (eMESH I) of the eSVS Mesh has commenced in Bern, Switzerland and anticipates first implants and enrollments under this study to begin the week of September 2, 2012. The objective of the eMESH I study remains the demonstration of initial safety and performance of the Kips Bay Medical eSVS Mesh sufficient to allow the FDA to approve an IDE for a pivotal study.
Simultaneously, Kips Bay Medical has begun the process of responding to the U.S. Food and Drug Administration’s (“FDA”) disapproval of its most recent IDE Application received on August 17, 2012. The IDE Application filed on July 19, 2012 sought approval to add four U.S. sites to the feasibility trial described above. In the letter received August 17, the FDA has requested additional information on the pre-clinical design testing of the eSVS Mesh that was referenced in the IDE Application. The Company is gathering the necessary information and will provide it to the FDA within 30 days in an 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 internal approvals of their institutional review boards and administration/finance departments to participate in the study.
Kips Bay Medical Founder, Manny Villafaña, said, “Despite the FDA response, we have received a significant level of interest and excitement about our eSVS Mesh by several leading U.S. cardiac surgeons who we recently introduced the product to in anticipation of a potential study here in the U.S.” Villafaña further stated, “Their high level of interest in and eagerness to study the eSVS Mesh is a tremendous motivator for me, and the Kips Bay team, to ensure that the clinical study of the eSVS Mesh is performed properly in both the U.S. and Europe.”