FDA Expands Kips Bay Medical’s eMesh 1 Clinical Trial

The FDA has cleared Kips Bay Medical to expand its eMesh 1 feasibility trial to 27 patients and at 10 U.S. study sites, the Minneapolis devicemaker said Monday. The agency initially approved the trial for up to15 patients at four sites.

Kips Bay is evaluating the feasibility and safety of the eSVS Mesh for external vein support over saphenous vein grafts during coronary artery bypass surgery. To date, 12 adults have enrolled.

Designed to mimic a natural artery, the device is made from nitinol wire and fits like a sleeve to strengthen saphenous vein grafts of 3.6 mm to 7 mm with double wall thicknesses of less than 1.4 mm. This prevents the vein graft from expanding, which could lead to injury or overall failure, the company said. The eSVS Mesh itself is 25 mm in length and comes in diameters of 3.5, 4 and 4.5 mm.

The mesh is guided to the vein using a delivery tube and loaded with the aid of a suture snare. It is CE-marked in Europe, where Kips Bay is expanding its use.

The company expects to conclude the expanded enrollment within thirty days. U.S. regulatory filing is several years off, CEO Manny Villafaña told Device Daily Bulletin, as the company must still conduct a pivotal trial. — Lena Freund

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