Sorin Group has received CE Mark approval for the Solo Smart stentless aortic valve, a unique bioprosthesis designed to replace the aortic valve without leaving a stent in place.
According to the company, the Solo Smart device is the next version of its Freedom Solo replacement valve.
Introduced in Europe in 2004, Freedom Solo is a stentless biological aortic heart valve with no synthetic material and proven outstanding haemodynamic and clinical performance.
The Solo Smart stentless aortic valve mimics the native aortic valve and preserves the aortic root physiology.
Solo Smart is intended to facilitate implantation by maintaining valve geometry and symmetry within the aortic root. It works more effectively over a larger area and leads to a major improvement in quality of life for patients.
It greatly improves the visibility during valve positioning and suturing and provides the patient with best-in-class haemodynamic performance. It also requires less time to complete valve suturing and reduces the learning curve for first-time users.
The new device features a removable stent to provide support while the valve is sewn in place and then removed.
Sorin Group cardiac surgery business unit president Michel Darnaud said that the company is excited to offer the Solo Smart valve, a unique technology that provides an excellent solution to physicians managing patients with aortic valve disease.
"We continue our commitment to improving cardiac surgery options with this significant contribution," Darnaud added.
The first European implantation of Solo Smart was successfully performed by Dr Alberto Repossini at Spedali Civili Brescia, Italy on 29 October.
Image: The stentless Solo Smart. Photo: courtesy of Sorin Group.