Kips Bay Medical, Inc. (NASDAQ: KIPS) along with Manny Villafaña, its Founder, Chairman and CEO, provides an FDA update and announces financial results for its third quarter ended September 29, 2012.
On November 8, 2012, the Company announced that the United States Food and Drug Administration (“FDA”) has granted conditional approval of Kips Bay Medical’s Investigational Device Exemption (“IDE”) to include four U.S. study sites in the “eMESH I” clinical feasibility trial of its eSVS® Mesh. The Company is currently working through the internal review and approval process with a number of leading cardiac centers in the United States.
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 enrollment of patients for this study commenced in Bern, Switzerland on August 31, 2012. 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 coronary artery bypass grafting (“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 in the eMESH I trial, at eight European and four U.S. sites.
In its approval, the FDA indicated that it will allow a staged enrollment within the United States starting with five patients. Kips Bay Medical will provide six-month follow-up angiogram data for five U.S. patients or, alternatively, a combination of 10 patients from inside and outside the United States, for the FDA to review prior to approving the remaining 35 U.S. patients initially requested by the Company.
In Europe, Kips Bay Medical continues to work through the ethics committee review and approval process at its selected clinical study sites. Three sites have received ethics committee approval and are in the process of recruiting patients for the study.