Boston Scientific announced the first two commercial implants of the Lotus Valve System have taken place in a German hospital. CE Mark approval for the Lotus Valve System was announced October 28 at the Transcatheter Cardiovascular Therapeutics Conference in San Francisco. Primary endpoint data from the REPRISE II clinical trial were presented at TCT. The data demonstrated that the Lotus Valve System was successfully implanted and correctly positioned in all 120 patients, and met the co-primary endpoints of mean aortic valve pressure gradient and all-cause mortality at 30 days. The Lotus Valve System is available at select centers in Europe with commercial site expansion accelerating as physicians and centers become fully trained. The Lotus Valve System is an investigational device in the United States and Japan and is not available for sale in these countries.
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