Edwards launches mitral valve device in U.S., Europe

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The Edwards Lifesciences Carpentier-Edwards Perimount Magna Mitral Ease heart valve, a pericardial tissue-based bioprosthetic device used during mitral heart valve replacement surgery, has been approved for use in the U.S. and Europe.

The Irvine, Calif.-based company said that the device maintains hemodynamics and is used to facilitate access, placement and suturing during heart valve surgeries. The device’s design is based on its predecessor, the Edwards Perimount mitral valve.

The company announced the device’s launch during the 24th annual meeting of the European Association for Cardio-Thoracic Surgery in Geneva, Switzerland.

In addition, at the Cardio-Thoracic meeting, Malakh Shrestha, MD, of the Hannover Medical School in Hanover, Germany, reported results for the Edwards Odyssey aortic valve platform, an investigational device currently being studied in Europe during the TRITON trial. Compared to conventional, aortic valve surgery, the minimally invasive, rapid deployment Odyssey platform was shown to decrease bypass and cross-clamp times by almost 50 percent at Hannover, according to Shrestha.

"The Odyssey platform is designed to simplify and facilitate minimally invasive aortic valve surgery, thereby enabling shorter cardiopulmonary bypass times due to its unique implantation method. We believe these procedural enhancements may also improve patient outcomes," said Donald E. Bobo, Jr., Edwards' corporate vice president of heart valve therapy.