Edwards Lifesciences touts 1-year real-world data for Sapien 3
Edwards Lifesciences (NYSE:EW) today presented 1-year data from a real-world trial of its Sapien 3 transcatheter aortic valve replacement showing a high survival rate and low rates of stroke and paravalvular leakage.
Data from the 1,946-patient Sapien 3 registry, presented at the EuroPCR conference in Paris by Dr. Olaf Wendler of London’s King’s College Hospital, showed a an 88.2% survival rate and a 1.1% disabling stroke rate in patients implanted via the transfemoral route. The moderate PVL rate was 2.7%, with no severe leakage, the Irvine, Calif.-based company said. The results are slated for publication in the European Heart Journal.
“These ‘real-world’ outcomes with the Sapien 3 valve in a commercial setting continue to support the compelling clinical case for transcatheter aortic valve replacement, and, once again, demonstrate consistency in clinical practice between pivotal studies and global commercial experience,” Wendler said in prepared remarks.
Edwards said most patients in the trial were treated via the transfemoral route and more than half had the procedure under conscious sedation. The study is slated to follow the patients for 5 years.
The device won its original CE Mark approval back in January 2014, with the U.S. federal safety watchdog following suit in June 2015.
In August 2016 the FDA expanded the Sapien 3 indication to include intermediate-risk patients. A month later Sapien 3 won CE Mark approval in the European Union for the intermediate-risk population.
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