Kips Bay Medical Provides FDA Update and Reports First Quarter 2012 Results
5/10/2012 11:20:10 AM
MINNEAPOLIS--(BUSINESS WIRE)--Kips Bay Medical, Inc. (NASDAQ: KIPS) today provides an FDA update and announced financial results for its first quarter ended March 31, 2012. As previously discussed, the Company is performing a feasibility trial in Europe which is designed to provide additional information to the U.S. FDA sufficient to allow the FDA to approve an investigational device exemption (“IDE”) for a pivotal study in the U.S. The Company is currently working through the ethics committee review and approval process at its selected clinical study sites in Europe. The Company expects to enroll up to 120 patients at 8 sites for this study, with a primary efficacy endpoint of graft patency, or openness, at six months. The Company expects to commence patient enrollment in the summer of 2012.
comments powered by