Healthcare Industry News:  mitral valve 

Devices Cardiology FDA

 News Release - September 25, 2007

SORIN GROUP: Announces U.S. FDA'S Authorization to Market Its Memo 3D(TM) Annuloplasty Ring in the United States

DENVER, Colo.--(HSMN NewsFeed)--The Sorin Group (MIL:SRN), the largest European cardiovascular company and world leader in medical technologies for cardiac surgery, announced today that it has received the U.S. Food and Drug Administration's authorization for marketing its MEMO 3D Semirigid Annuloplasty Ring in the USA.

Annuloplasty rings are indicated for repair of the mitral valve and are designed to remodel the anatomical shape of the mitral annulus, preventing further dilatation and minimizing the risk of late repair failures.

"Due to its innovative core structure, the MEMO 3D ring restores the natural mitral annulus' three-dimensional motility during the cardiac cycle" said Franco Vallana, Chief Scientific Officer, Sorin Group. "mitral valve repair has become the therapy of choice for mitral valve disease and we believe that the MEMO 3D provides a unique solution for surgeons worldwide."

The Sorin Group's MEMO 3D annuloplasty ring has already been introduced in several European countries. Prof. Joachim Gerd Rein (Sana Clinic, Stuttgart, Germany) who has implanted over 140 MEMO 3D annuloplasty rings at his center, reports: "Initial clinical results confirm our expectations in terms of ease of implant, variable flexibility and physiological behaviour."

"The introduction of this annuloplasty ring will represent a real step forward in mitral valve repair," said Dr. Clark Hargrove (Penn Presbyterian Medical Center, Philadelphia, PA, US). "The MEMO 3D's very innovative core technology will allow more versatility in the treatment of the different pathologies that affect mitral valves with respect to current available devices."

The MEMO 3D will be distributed in the United States by CarboMedics Inc., Sorin Group's United States subsidiary.

About MEMO 3D Semirigid Annuloplasty Ring
  • Innovative cell-structure design, capable of mimicking the physiological three-dimensional motility of the native mitral annulus and accommodating the anatomical saddle shape;
  • Shape memory and super-elastic alloy core, aimed at restoring the native shape and function;
  • Sorin Group's exclusive Carbofilm(TM) coating for enhanced hemo-compatibility;
  • Ease of implant due to suture placement guides, a low profile holder and a special configuration of the silicon filler.
About the Sorin Group

The Sorin Group (Bloomberg: SRN.IM; Reuters: SORN.MI), a world leader in the development of medical technologies for cardiac surgery, offers innovative therapies for cardiac rhythm dysfunctions, interventional cardiology and the treatment of chronic kidney diseases. The Sorin Group includes these brands: Dideco, CarboMedics, COBE Cardiovascular, Stockert, Mitroflow, ELA Medical, Sorin Biomedica, Bellco and Bellco-Soludia. At the Sorin Group 4,500 employees work to serve over 5,000 public and private treatment centers in more than 80 countries throughout the world. For more information, please visit: www.sorin.com


Source: SORIN GROUP

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