FDA Approves Sorin’s Solo Smart™, First Stentless Fully Biological Valve

Italian cardiovascular device maker Sorin Group, has gained U.S. FDA approval for the Solo Smart™ Aortic Pericardial Heart Valve which the company claims is the first biological valve to feature a fully removable stent.

Background

If achieving a result that’s a close to a native valve as possible is your aim, then Sorin’s Solo Smart might be your answer. The device is the first of its kind to be approved in the U.S. market. It possesses a Ni-Ti alloy stent which supports the valve during insertion but is then removed in its entirety, leaving a fully biological, bovine pericardium-based bioprosthesis. By preserving the aortic root physiology, perfectly alignment to the patient’s annulus is achieved, with a 100% orifice-to-annulus ratio. The design goal is to maximize blood flow and delivers excellent hemodynamic performance, thereby mimicking the healthy native aortic valve.

An evolution of Sorin’s Freedom Solo valve, the Solo Smart valve differs in being the only such device to feature a removable Ni-Ti alloy stent. This feature, combined with the single-suture line implant technique reduces the time spent seating and suturing the valve. In another time-saving measure, the prosthesis is pre-treated for the elimination of aldehyde residuals so it doesn’t require rinsing prior to implantation.

Once the stent is removed following implantation, Solo Smart becomes an entirely stentless valve, providing low pressure gradients and large orifice areas.

Physician comments 

“I am very excited to begin implanting the Solo Smart valve, said David Heimansohn, M.D., 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 hemodynamics while reducing the length of surgery”.

Company comments

“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”, said Michel Darnaud, President, Cardiac Surgery Business Unit, Sorin Group. “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.”

Source: Sorin Group, Business Wire

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