Sorin Group has announced that it has received US Food and Drug Administration (FDA) approval for the Solo Smart aortic pericardial heart valve.
Solo Smart is the first valve with a removable stent to be approved in the US market. Designed from bovine pericardium, the valve is fully biological with no synthetic material added. This unique bioprosthesis mimics the healthy native aortic valve in order to preserve the aortic root physiology. By perfectly aligning to the patient’s annulus with a 100% orifice-to-annulus ratio, Solo Smart maximises blood flow and delivers excellent haemodynamic performance, Sorin reports.
The removable Ni-Ti alloy stent sets Solo Smart apart from all other valves, as this unique feature provides support during implantation and is then completely removed. The removable stent along with the single-suture line implant technique reduces the time spent seating and suturing the valve. The prosthesis is treated for the elimination of aldehyde residuals so it is not necessary to rinse the valve before implantation. Once the stent is removed following implantation, Solo Smart becomes an entirely stentless valve, providing low pressure gradients and large orifice areas.
Solo Smart is the evolution of the Freedom Solo valve, which has been implanted in international markets since 2004. This valve has been evaluated in numerous clinical studies representing over 4,000 patients with follow-up to eight years.
“I am very excited to begin implanting the Solo Smart valve,” says David Heimansohn, St Vincent Heart Center, Indianapolis, Indiana, USA, who participated in the US IDE clinical study. “Solo Smart is the closest bioprosthesis to the native aortic valve and allows me to offer my patients a solution that provides superior haemodynamics while reducing the length of surgery.”