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.
From the press release:
“The Solo Smart valve combines superior hemodynamic performance and ease of implant making it a very attractive solution for aortic valve replacement, especially in patients with superior hemodynamic requirements”, said [Alberto Repossini, M.D. at Spedali Civili Brescia, Italy]. “The Solo Smart valve mimics the native aortic valve and preserves the aortic root physiology. It ensures an excellent hemodynamic performance in terms of larger effective orifice area as well as mean and peak gradients that remain stable over the follow-up period, leading to a remarkable clinical improvement”, added Dr. Repossini.
Press release: Sorin Group announces CE Mark approval and first implant of the new Solo Smart™ Biological Aortic Pericardial Heart Valve…
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