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Edwards Lifesciences Corp. today announced that it received Food and Drug Administration approval for its Sapien 3 platform in asymptomatic patients with severe aortic stenosis.
It marks the first approved transcatheter aortic valve replacement therapy in asymptomatic patients, according to the company.
“There is an urgent need to change practice and TAVR guidelines for the treatment of aortic stenosis patients, which currently recommend ‘watchful waiting’ until symptoms develop,” Dr. Philippe Genereux, director of the structural heart program at Gagnon Cardiovascular Institute at Morristown Medical Center, said in a statement.
Shares in Edwards were little changed at $75.20 and a $44 billion market cap following the announcement (NYSE: EW).
See the May 12 edition of the Business Journal for more information.