The company claims that Solo Smart, which is developed from bovine pericardium, is the first valve with a removable stent to be approved in the US.

The aortic pericardial heart valve has no synthetic material and is fully biological. The bioprosthesis is similar to the healthy native aortic valve in order to preserve the aortic root physiology, the company said.

Solo Smart maximizes blood flow and delivers better hemodynamic performance by aligning to the patient’s annulus with a 100% orifice-to-annulus ratio.

The device features a Ni-Ti alloy stent which provides support during implantation and is then completely removed. According to Sorin, the removable stent along with the single-suture line implant technique reduces the time spent seating and suturing the valve.

As the prosthesis is treated for the elimination of aldehyde residuals, it is not necessary to rinse the valve before implantation, the company added. Solo Smart becomes an entirely stentless valve after removing the stent.

Sorin Cardiac Surgery business unit president Michel Darnaud said: "We are pleased to provide patients and cardiothoracic surgeons in the US with the Solo Smart valve, a unique technology that offers superior hemodynamics and clinical outcomes.

"This is an important milestone for Sorin Group and reinforces our commitment to provide innovative solutions tailored to the needs of cardiac surgeons and their patients worldwide."

Solo Smart is the evolution of the Freedom Solo valve which is being sold since 2004. This valve has been evaluated in numerous clinical studies representing over 4,000 patients with follow-up to eight years.

Image: Sorin’s Solo Smart aortic pericardial valve with a removable stent. Photo: Courtesy of Business Wire