Kips Bay Medical, a medical device company based in Minneapolis, Minnesota, announced that it had received go-ahead approval from the United States Food and Drug Administration (FDA) for a clinical trial of its eSVS Mesh system.
The original clinical study for the eSVS Mesh system commenced on August 31st, 2012 in Bern, Switzerland. With FDA approval, the company will add four U.S.-based study sites to its clinical trial. According to the approval, the FDA will grant the company the ability to start a staged enrollment with five patients. The company will then provide a follow-up after six months with angiogram data for the five patients. This may be combined with angiogram data for up to 10 patients outside the United States. Kips Bay Medicals has requested FDA approval for an additional 35 U.S. patents on its medical technology. However, the FDA’s approval of these remaining patents is not assured.
The clinical trial is designed to test the efficacy of the eSVS Mesh system in external saphenous vein graft (SVG) surgeries. The device will be used for external SVG support during a bypass of the coronary artery. The eSVS Mesh consists of a nitinol mesh sleeve that improves long-term performance and structural characteristics of an SVG.
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