Manny Villafaña, Chairman and Chief Executive Officer of Kips Bay Medical (NASDAQ: KIPS), announced that the FDA continues to require additional information from the Company prior to allowing the Company to pursue a clinical study of its eSVS ® MESH in the United States. In its most recent communication, the FDA has advised the Company that, at this time, it does not believe that the Company has provided sufficient data to support the Company’s request for an investigational device exemption (“IDE”) for the eSVS MESH. The FDA also indicated that it will review such additional information when it becomes available.
The Company has been and will continue to diligently pursue additional clinical studies in Europe and the United Arab Emirates (“UAE”) which are intended to generate data on the efficacy of the eSVS MESH to support clinical usage and reimbursement decisions internationally. The Company believes that the results from the European studies will provide the additional data necessary to obtain an IDE from the FDA.
Over the next three months, Kips Bay expects to initiate several post market clinical studies of the eSVS Mesh for use with saphenous vein grafts during coronary artery bypass surgery. These studies will primarily involve several prestigious cardiovascular centers across Europe. These controlled clinical studies will assess short term and long term patency of saphenous vein grafts treated with the eSVS Mesh.
The European studies will include one large prospective, multi-center, randomized, controlled clinical study in 300 patients assessing the short (three to six-month) and long term (two-year) patency of the eSVS Mesh compared to a control graft without an eSVS Mesh; and one prospective, multi-center registry study assessing the short term (six-month) patency of the eSVS Mesh by CT angiography in 100 patients. In the 100 patient registry study, all saphenous vein grafts eligible for the eSVS Mesh will receive a device which will help address the role of the eSVS Mesh during routine coronary artery bypass procedures.