The US Food and Drug Administration (FDA) has granted approval for Italy-based medical company Sorin's Solo Smart aortic pericardial heart valve.
The company claims that Solo Smart is the first aortic valve with a removable stent to be approved in the US, providing native-like performance with the ease of implant of a stented valve.
Designed from bovine pericardium, Sorin claims that Solo Smart is fully biological as it does not have any synthetic material. This bioprosthesis is similar to the healthy native aortic valve, which preserves the aortic root physiology.
Solo Smart increases blood flow and deliver better hemodynamic performance by aligning well to the patient's annulus with a 100% orifice-to-annulus ratio.
Compared to other valves, Solo Smart features a Ni-Ti alloy stent that provides support during implantation and is then completely removed.
The company said that 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 removal of aldehyde residuals, it is not necessary to rinse the valve before implantation, the company said.
Solo Smart becomes an entirely stentless valve once the stent is removed after implantation, providing low-pressure gradients and large orifice areas.
St Vincent Heart Transplant team member David Heimansohn said: "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."
Solo Smart has been evaluated in several clinical studies representing over 4,000 patients with follow-up to eight years.
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."
Image: Sorin Group's Solo Smart is the first aortic pericardial valve with a removable stent. Photo: courtesy of Business Wire.