Edwards SAPIEN Transcatheter Heart Valve Training Program Launches In Europe

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Heart Valve Training Program

Medical Simulation Corporation launches Edwards SAPIEN Transcatheter Heart Valve (THV) Training Program in Europe.

Edwards Lifesciences Corporation, the world leader in the science of heart valves, received CE Mark approval for European commercial sales of its Edwards SAPIEN transcatheter aortic heart valve with the RetroFlex transfemoral delivery system in September, 2007, and CE Mark for the Edwards SAPIEN valve with the Ascendra transapical delivery system in December, 2007 .

Medical Simulation Corporation and Edwards Lifesciences have worked together since 2004 to develop a comprehensive THV procedure training program for surgeons and cardiologists during U.S., Canadian and European clinical trials. With CE Mark approval in Europe, the training program is now focused on providing commercial product training for physicians that includes online training, an advanced combination of didactic and simulation education integrated with cases studies and hands-on product education with expert physician proctoring.

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"Simulators contribute tremendously giving physicians the opportunity to become familiar with the procedure before they actually have to perform it in patients," John Webb, MD, St. Paul's Hospital, Vancouver, BC and Physician Course Director for THV Simulation Development.

Medical Simulation Corporation's SimSuite simulation technology fully integrates the THV product into a comprehensive patient simulator, allowing physician trainees to conduct the procedure as close to real life as possible, including managing early learning-curve complications that can now be avoided with proper techniques learned in the clinical trials.

"This program is very unique in that we have designed the most advanced simulation education program to train both surgeons and cardiologists together on one of the most complex procedures being performed with catheters," says Bill Younkes, CEO of Medical Simulation Corporation. "Edwards has made a commitment to provide the best training available to its customers with the ultimate goal of a well-served patient. The transfer of knowledge that occurs with this level of education is clearly a huge step forward in the healthcare industry."

The Edwards SAPIEN THV integrates balloon-expandable stent technology that leverages Edwards' proprietary bovine pericardial tissue and 30 years of design and manufacturing expertise. The Edwards SAPIEN valve is compressed onto a balloon to the approximate diameter of a pencil and then either threaded through the patient's circulatory system from the leg (transfemoral delivery) or inserted between the ribs (transapical delivery) and deployed across the patient's diseased aortic valve -- all while the heart continues to beat. In both cases, the procedure is completed without open-heart surgery or cardiopulmonary bypass, providing an important treatment option for patients considered to be high-risk for traditional open-heart surgery.

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