
Sorin Group (BIT:SRN) said it won CE Mark approval in the European Union for its Solo Smart heart valve, designed to replace the aortic valve without leaving a stent in place.
Milan-based Sorin said the Solo Smart device is the next iteration of its Freedom Solo replacement valve. The new device features a removable stent to provide support while the valve is sewn in place and then removed, according to a press release.
The 1st implantation of the device, by Dr. Alberto Repossini of the Spedali Civili Brescia, was performed Oct. 29, Sorin said.
"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," Repossini said in prepared remarks. "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."
"We are very excited to offer the Solo Smart valve, a unique technology that provides an excellent solution to physicians managing patients with aortic valve disease," added Sorin cardiac surgery president Michel Darnaud. "We continue our commitment to improving cardiac surgery options with this significant contribution."