CEO of Kips Bay Medical (KIPS) Announcs Disappointment With FDA Following Clinical Study of eSVS MESH
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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 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.
Mr. Villafaña said “While we are disappointed with the news from the FDA, we remain confident that our European studies will demonstrate the improved patency of grafts treated with the eSVS Mesh as compared to untreated grafts. We will then present this data to the FDA as further evidence supporting our request for an IDE.”
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 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.
Mr. Villafaña said “While we are disappointed with the news from the FDA, we remain confident that our European studies will demonstrate the improved patency of grafts treated with the eSVS Mesh as compared to untreated grafts. We will then present this data to the FDA as further evidence supporting our request for an IDE.”
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