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Sorin Group S.p.A. (SRN) Wins CE Mark Approval For Stentless Heart Valve


11/22/2013 6:23:15 AM

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Sorin Group Announces CE Mark Approval and First Implant of the New Solo Smart(TM) Biological Aortic Pericardial Heart Valve

MILAN--(BUSINESS WIRE)-- Sorin Group (SRN.MI), (Reuters Code: SORN.MI), a global medical company and a leader in the treatment of cardiovascular diseases, announced today that it has received CE (Conformité Européenne) Mark approval for the Solo Smart stentless aortic 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 20041.This unique bioprosthesis is designed to respect the aortic root physiology and ensure a physiological blood flow through the valve annulus. This allows the Solo Smart valve to behave 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.

The first European implantation of Solo Smart was successfully performed by Alberto Repossini, M.D. at Spedali Civili Brescia, Italy on October 29th, 2013.

“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.

“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.”

[1] A. Repossini, M. Rambaldini, V. Lucchetti, U. Da Col, F. Cesari, C. Mignosa, E. Picano and M. Glauber; Eur J Cardiothorac Surg. 2012;41(5):1104-111.

About Sorin Group

Sorin Group (www.sorin.com) is a global, medical device company and a leader in the treatment of cardiovascular diseases. The Company develops, manufactures, and markets medical technologies for cardiac surgery and for the treatment of cardiac rhythm disorders. With 3,750 employees worldwide,Sorin Group focuses on two major therapeutic areas: Cardiac Surgery (cardiopulmonary products for open heart surgery and heart valve repair or replacement prostheses) and Cardiac Rhythm Management (pacemakers, defibrillators and non invasive monitoring to diagnose arrhythmias and deliver anti-arrhythmia therapies as well as cardiac resynchronization devices for heart failure treatment) Every year, over one million patients are treated with Sorin Group devices in more than 80 countries.

For more information, please visit www.sorin.com

Contact:

Gabriele Mazzoletti

Director, Corporate Communications

Sorin Group

Tel: +39 02 69969785

Mobile: +39 348 9792201

e-mail: gabriele.mazzoletti@sorin.com

or

Francesca Rambaudi

Director, Investor Relations

Sorin Group

Tel: +39 02 69969716

e-mail: investor.relations@sorin.com

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