Kips Bay Medical ($KIPS) is trying for the second time to gain an investigational device exemption from the FDA that would expand a feasibility study of an artery bypass graft mesh device to four U.S. sites.
The device--the eSVS Mesh--is a nitinol mesh sleeve placed over a saphenous vein graft during coronary artery bypass grafting surgery, in order to improve the quality and performance of the graft.
As MedCity News explains, regulators turned down the company's first IDE application last fall, asking for the sometimes-dreaded "additional information." The second time will hopefully be the charm. Minneapolis, MN-based Kips Bay submitted the additional study details in April, and the FDA allowed it to move ahead with a full IDE, which is a positive sign. Regulators have 30 days to respond to the IDE application, according to the company.
Right now, Kips Bay continues to pursue a feasibility study at 8 cardiac centers in Germany, Switzerland, Italy and France. Plans call for enrolling up to 120 patients in Europe and at the four U.S. cardiac centers. Researchers hope to demonstrate that the product is safe and performs well to the point that regulators will expand the feasibility study into a pivotal study. So far, the company has used the device for more than 350 implants overseas.
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