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FDA approves pericardial heart valve with removable stent

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The Sorin Group announced that the FDA has approved the Solo Smart Aortic Pericardial Heart Valve.

The valve is the first with a removable stent to be approved in the United States, according to a company press release. The approval follows results from several clinical trials that included more than 4,000 patients and up to 8 years of follow-up.

The Solo Smart valve is made from bovine pericardium and contains no synthetic material. It is intended to mimic a healthy aortic valve and preserve aortic root physiology. The valve features a removable alloy that aids the implantation process, but is then removed. When implanted via a single-suture line technique, the removable stent reduces time spent seating and suturing the valve, according to the release.

“I am very excited to begin implanting the Solo Smart valve,” David Heimansohn, MD, of St. Vincent Heart Center in Indianapolis and participant in the US IDE clinical trial, said in the release. “Solo Smart is the closest bioprosthesis to the native aortic valve, and allows me to offer my patients a solution that provides superior hemodynamics while reducing the length of surgery.”