Sorin has announced that its Solo Smart device, a stentless and biological aortic heart valve with no synthetic material, has received CE mark approval and has been implanted for the first time. A press release reports that the device is designed to respect the aortic root physiology and ensure a physiological blood flow through the valve annulus. It adds that this allows the Solo Smart valve to behave like a healthy native valve, thus restoring quality of life for patients.
The press reports that building on this heritage of Sorin’s Freedom solo valve, Solo Smart now features a removable stent that gives support to the valve and is intended to facilitate implantation by: maintaining valve geometry and symmetry within the aortic root, improving visibility during valve positioning and suturing, requiring less time to complete valve suturing, and reducing learning curves of first-time users. Once the valve is sutured to the aortic root, the stent is removed leaving the stentless valve in place.
The first European implantation of Solo Smart was performed by Alberto Repossini at Spedali Civili Brescia, Italy on October 29th, 2013. Repossin says: “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. It 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.”