Sorin Group S.p.A. Gets CE Mark For Solo Smart Biological Heart Valve

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Sorin Group (Milan, Italy) has been awarded CE mark approval for the Solo Smart, a stentless aortic valve implant. Like its predecessor, the Freedom Solo valve, it is a biologic device that contains no synthetic material. The Solo Smart uses a stent to provide support while the replacement valve is sutured to the aortic root, at which point the stent is removed. Without the rigid frame of a stent altering normal physiological blood flow, the Solo Smart is able to perform more like a native valve. Sorin expects the unique bioprosthesis to improve procedure visibility for suturing, thereby reducing procedure time and maintaining a learning curve similar to that of a stented valve implant.

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