April 28, 2014 11:58 UTC

Sorin Group Receives FDA Approval for the Mitroflow (TM) Aortic Heart Valve with New Phospholipid Reduction Treatment

The Phospholipid Reduction Treatment (PRT) on the Mitroflow Aortic Pericardial Heart Valve is designed to further improve durability

MILAN--(BUSINESS WIRE)-- Sorin Group, (MIL:SRN) (Reuters Code: SORN.MI), a global medical company and a leader in the treatment of cardiovascular diseases, announced today that it received U.S. Food and Drug Administration (FDA) approval for the Mitroflow Aortic Pericardial Heart Valve with PRT.

The Phospholipid Reduction Treatment (PRT), a patented advanced tissue treatment, is intended to further improve durability of the Mitroflow bioprosthetic valve. Research has demonstrated that phospholipids play a key role in the calcification process of bioprotheses. PRT has been shown to decrease phospholipid content in pericardial tissue, which led to a reduction of 99% of calcium uptake compared to control1.

With over 30 years of clinical use and over 20 years of exceptional peer-reviewed clinical outcomes, the Mitroflow valve has demonstrated excellent hemodynamic performance due to its proven design. The addition of PRT will help mitigate potential calcification and may further improve the tissue valve’s clinically proven outstanding durability.

“I am excited to begin implanting the new Mitroflow with PRT,” said Wilson Szeto, M.D., Cardiac Surgeon at the University of Pennsylvania Medical Center in Philadelphia. “Mitroflow has a history of excellent clinical results, and this treatment will help us to further improve the durability of the valve for my patients.”

This enhancement demonstrates Sorin Group’s unwavering commitment to innovation and improvement of its tissue heart valve portfolio. “We are extremely pleased to receive FDA approval for the Mitroflow valve with PRT”, said Michel Darnaud, President, Cardiac Surgery Business Unit, Sorin Group. “There have been over 165,000 implants of Mitroflow valves worldwide, and Mitroflow with PRT has been well received in Europe since its launch in 2011. We trust the proven excellent performance of Mitroflow and we are pleased to provide patients and cardiothoracic surgeons with PRT which will potentially advance the valve’s proven long-term durability.”

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 prostheses and repair devices) 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

1 Based on 30-day animal model, Sorin Group 2011, data on file.

Contacts

Gabriele Mazzoletti, Tel: +39 02 69969785
Mobile: +39 348 9792201
Director, Corporate Communications
Sorin Group
e-mail: gabriele.mazzoletti@sorin.com
or
Francesca Rambaudi, Tel: +39 02 69969716
Director, Investor Relations
Sorin Group
e-mail: investor.relations@sorin.com


Source: Sorin Group