Global medical company Sorin has announced the CE Mark approval and first implantation of the new Solo Smart biological aortic pericardial heart valve in Europe.
Solo Smart is the evolution of the company's Freedom Solo pericardial aortic valve. The stentless Freedom Solo valve has no synthetic material and has been designed to maximize the blood flow for excellent hemodynamic performance.
This stentless heart valve has been demonstrating outstanding hemodynamic and clinical performance since 2004.
The Solo Smart stentless aortic valve features a removable stent that supports the valve.
The removable stent facilitates the implantation by maintaining valve geometry and symmetry within the aortic root and improving visibility during valve positioning and suturing.
Once the valve is sutured to the aortic root, the stent is removed leaving the stentless valve in place.
Dr Alberto Repossini at Spedali Civili Brescia, Italy has successfully performed the first European implantation of Solo Smart on 29 October 2013.
According to Dr Repossini, 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.
"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," Dr Repossini added.
Sorin Cardiac Surgery business unit president Michel Darnaud noted the company is very 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.
Solo Smart provides native-like heart valve performance.