Sorin Group Receives Regulatory Approval to market Memo 3Dtm Annuloplasty Ring in Japan
Tokyo, Japan, May, 16 2012. - Sorin Group, (Reuters Code: SORN.MI), a global medical device company and a leader in the treatment of cardiovascular diseases, announces that it received authorization from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) to market its MEMO 3D Semi-Rigid Annuloplasty Ring. The first MEMO 3D implant was performed at the KobeCity Medical Center General Hospital.
Annuloplasty rings are indicated for repair of the mitral valve and are designed to remodel the anatomical shape of the mitral annulus, thus preventing further dilatation and minimizing the risk of late repair failures.
Sorin's MEMO 3D Semi-Rigid Annuloplasty Ring is already marketed in several European countries and in the United States.
The main features of Sorin’s MEMO 3D Semi-Rigid Annuloplasty Ring include:
- An innovative cell-structure design, capable of mimicking the physiological three-dimensional motility of the native mitral annulus and accommodating the anatomical saddle shape;
- A shape memory and super-elastic alloy core, aimed at restoring the native shape and function;
- Sorin's exclusive Carbofilm™ coating for enhanced hemo-compatibility;
- Suture placement guides, a low profile holder and a special configuration of the silicon filler for ease of implant.
Dr. Okada who successfully performed the first procedure of mitral valve repair with MEMO 3D at the Kobe City Medical Center General Hospital stated: “Due to its semi-rigid design and Carbofilm coating, MEMO 3D is expected to provide continuous physiological motion of the mitral annulus after mitral valve repair”.
Prof. Fischlein (Klinikum Nürnberg, Nuremberg, Germany) who implanted over 100 MEMO 3D rings reported: “We had the privilege of implanting this semi-rigid ring for the first time in man. The MEMO 3D ring capability to preserve mitral annulus flexibility has been confirmed by our magnetic resonance images, obtained after more than 5 years post-implantation, the longest follow-up period ever reported. We recommend using a complete annuloplasty ring to mimic the physiological three-dimensional motion of the native mitral annulus and preserve the sphincter mechanism of the valve”.
“We are extremely pleased to bring MEMO 3D unique technology to Japanese cardiac surgeons and their patients”, said Davide Bianchi, Sorin Group President Heart Valve Business Unit. “Mitral valve repair has become the therapy of choice for mitral valve disease and we believe that the MEMO 3D ring is the right solution for this type of procedure”, he added.
MEMO 3D Semi-Rigid Annuloplasty Ring is distributed in Japan by Japan Life Line.
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, the Group focuses on three major therapeutic areas that include: cardiopulmonary bypass (extracorporeal circulation and autotransfusion systems), cardiac rhythm management, and heart valve repair and replacement. Every year, over 1 million patients are treated with the devices of Sorin Group in more than 80 countries.
For more information, please visit www.sorin.com, or contact:
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