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Sorin receives US FDA approval for annuloplasty ring in the USA

Sorin : 25 September, 2007  (New Product)
The Sorin Group has received the US Food and Drug Administration's authorisation 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 minimising 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 centre, 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, Pennsylvania, USA).

“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 USA by CarboMedics, Sorin Group's US subsidiary.

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