Medical Devices / Submissions and Approvals

FDA Approves First Removable Stent Heart Valve

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Cardiovascular devicemaker Sorin Group said Tuesday it has received FDA premarket approval for the Solo Smart Aortic Pericardial Heart Valve. The device is the first valve with a removable stent to be approved in the U.S.

The fully biological valve is made from cow pericardium and has no added synthetic material, the Milan, Italy, devicemaker said. It mimics a healthy aortic valve in order to preserve the aortic root physiology and completely aligns to the patient’s annulus, maximizing blood flow and delivering superb hemodynamic performance, the company added.

What sets the Solo Smart apart from other valves is the removable Ni-Ti alloy stent, which is removed after providing support during implantation. This feature, combined with a single-suture attachment, reduces the time spent positioning and suturing the valve, Sorin said.

Solo Smart is an evolution of the Freedom Solo Stentless heart valve, which was commercialized in 2004. It received a CE mark last November. — Kellen Owings

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