Kips Bay Medical, Inc. (NASDAQ: KIPS) along with Manny Villafaña, its Founder, Chairman and CEO, today provided an update on its progress with the U.S. FDA and announced financial results for fourth quarter and year ended December 31, 2012.
- Receipt of IDE approval with conditions from the U.S. FDA.
- U.S. FDA approves enrollment expansion to 15 patients in the U.S.
- First eSVS Mesh Implants in the U.S.
- U.S. FDA removes conditions from IDE approval.
Kips Bay is currently conducting a feasibility trial in the United States and Europe. This trial is a multi-center, randomized study of external saphenous vein graft (“SVG”) support using the Company’s eSVS
Mesh in CABG Surgery and is titled the
clinical feasibility trial. The objective of this trial is to demonstrate the initial safety and performance of the Company’s eSVS Mesh for use as an external SVG support device during coronary artery bypass procedures. Kips Bay Medical expects to enroll up to 120 patients at eight European and four U.S. sites. Enrollments in the
trial commenced in late August 2012 at the Bern University Hospital, Bern, Switzerland. The primary safety endpoint is the rate of major adverse cardiac events (“MACE”) within 30 days of the procedure. The eSVS Mesh performance will be evaluated based upon the angiographic patency rate of the enrolled grafts, where patency is defined as less than 50% stenosis, or blockage, of the SVG at six months after surgery. As of March 1, 2013, six sites in Europe and the United States have received ethics committee approval and are actively recruiting patients. The Company expects to use the data from this study as the basis for the filing of a request for an Investigational Device Exemption (“IDE”) to perform a pivotal trial in the United States and Europe.
On November 8, 2012, Kips Bay announced that the U.S. Food and Drug Administration (“FDA”) had approved with conditions our application for an IDE to include four U.S. study sites in the
clinical feasibility trial of the Company’s eSVS Mesh. In its approval, the FDA indicated that it was allowing a staged enrollment within the United States starting with five patients. In January 2013, the FDA expanded their approval to allow for 15 patients. The Company 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. If the FDA determines that these angiograms are acceptable, the Company expects to receive the approval from the FDA to enroll the remaining 35 U.S. patients initially requested by the Company.
In February-March 2013, the first three U.S. patients were implanted with the eSVS Mesh at the Northeast Georgia Medical Center in Gainesville, Georgia. These implants were performed as part of the Kips Bay Medical
clinical feasibility trial.
On March 7, 2013, in response to additional information the Company provided to the FDA, the FDA notified the Company that it had satisfactorily addressed the conditions indicated by the FDA in the Agency’s November 8, 2012 approval noted above.