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Examples
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"The Sapien Transcatheter Heart Valve is an example of an innovative new device that will provide some people with this condition who can't undergo open heart surgery with the option of valve replacement," said Jeffrey Shuren , director of the FDA's Center for Devices and Radiological Health.
Edwards Lifesciences's Less-Invasive Heart Valve Approved by FDA Anjali Athavaley 2011
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Transcatheter valves, made by Edwards and competitor Medtronic, are threaded through a leg artery up to the heart – and don't require removing the old valve.
New Technology Makes Heart Valve Replacement Less Invasive 2010
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Transcatheter valves are anticipated to cost $20,000 to $30,000 but to bring lower hospital bills.
New Technology Makes Heart Valve Replacement Less Invasive 2010
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Dr. Mauri was among several researchers and company and Food and Dr.g Administration officials who discussed the study Wednesday at the annual Transcatheter Cardiovascular Therapeutics conference.
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The study, released Thursday at the annual Transcatheter Cardiovascular Therapeutics heart conference, may raise questions about a heart device Medtronic has highlighted for its safety.
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Results from that study, known as FAME, were presented here at the annual Transcatheter Cardiovascular Therapeutics meeting of cardiologists and medical-device manufacturers.
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Transcatheter heart valve sales were $82.6 million, a 69.1 percent increase over 2010, or 50.0 percent on an underlying basis, primarily driven by strong procedure growth.
unknown title 2011
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Transcatheter sales generated $206 million last year for Edwards, according to data compiled by Bloomberg.
unknown title 2011
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The FDA Circulatory Systems Devices Panel has given a strong vote of support in favor of the Sapien Transcatheter Heart Valve THV for use in patients with inoperable severe aortic stenosis and with no co-morbidities precluding benefit from correction of the aortic stenosis.
Forbes.com: News Larry Husten 2011
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Transcatheter sales generated $206 million last year for Edwards, according to data compiled by Bloomberg.
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