CE Mark and First Implant for Sorin’s “Removable Stent” Biological Valve

Italian Cardiovascular device company Sorin Group, has received CE Mark approval for the Solo Smart stentless aortic valve. A first European implantation of Solo Smart was successfully performed by Alberto Repossini, M.D. at Spedali Civili Brescia, Italy on October 29th, 2013.

Background

It’s not often we report on a “new” conventional heart valve, most of the buzz being about transcatheter devices. Sorin’s new offering however is truly stentless and as such offers something interesting to physicians wanting to mimic the natural valve.

Solo Smart is the evolution of the Freedom Solo valve, a truly stentless and a totally biological aortic heart valve with no synthetic material and proven outstanding hemodynamic and clinical performance since 2004.The unique bioprosthesis designed is said to respect the aortic root physiology and ensure a physiological blood flow through the valve annulus. This allows Sorin to claim that its Solo Smart valve behaves like a healthy native valve, thus restoring quality of life for patients.

Building on this heritage, 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
  • 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, with the benefits of excellent hemodynamic results.

Physician comments 

“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 Dr. Repossini. “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.

Company comments

“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”, said Michel Darnaud, President, Cardiac Surgery Business Unit at Sorin Group. “We continue our commitment to improving cardiac surgery options with this significant contribution.”

Source: Sorin Group, SpA., Business Wire

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