Kips Bay Medical,Inc. (NASDAQ: KIPS) is dedicated to providing therapeutic vascular technologies for the cardiac surgeon to better treat cardiovascular disease.
Recently KIPS announced that the United States Food & Drug Administration (FDA) has granted approval for additional US patients to be enrolled in Kips Bay Medicals eMESH I clinical feasibility trial of its eSVS Mesh. At this stage, the FDA increased the approved number of patients from five to fifteen.
Kips Bay Medical will provide six month follow-up angiograms on the first ten patients, from the U.S. and Europe combined, for the FDA to review. If the FDA determines that these angiograms are acceptable, Kips Bay Medical expects to receive the approval from the FDA to enroll the remaining U.S. patients.
The eMESH I clinical feasibility trial is a multi-center, randomized study of external saphenous vein support using Kips Bay Medicals eSVS Mesh in CABG Surgery. 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 (SVG) support device during coronary artery bypass (CABG) surgery. The Company expects to enroll up to 120 patients at eight European and four U.S. sites and further expects to use the data from this study as the basis for a pivotal trial in the U.S.