Sorin Group nabs CE mark for aortic heart valve
The European Union has granted Sorin Group a CE mark for its self-anchoring Perceval S aortic heart valve, which is indicated for minimally invasive aortic valve replacement surgery for patients with aortic stenosis.
The device is equipped with a self-anchoring frame that enables the surgeon to replace the diseased valve without suturing it into place, the company said. In addition, the valve is made of bovine pericardium and is mounted to a super-elastic alloy frame.
According to the Milan, Italy-based Sorin, past clinical trial results have shown that in 180 patients implanted with the device, procedural time for isolated and complex aortic valve replacement was reduced by 50 percent.
The device is equipped with a self-anchoring frame that enables the surgeon to replace the diseased valve without suturing it into place, the company said. In addition, the valve is made of bovine pericardium and is mounted to a super-elastic alloy frame.
According to the Milan, Italy-based Sorin, past clinical trial results have shown that in 180 patients implanted with the device, procedural time for isolated and complex aortic valve replacement was reduced by 50 percent.