Edwards Lifesciences gains FDA approval for Sapien 3 Ultra system

Edwards Lifesciences announced Friday that the FDA approved the Sapien 3 Ultra system for transcatheter aortic valve replacement in severe, symptomatic aortic stenosis patients who are determined to be at intermediate or greater risk of open-heart surgery. Earlier this year, the product received the CE mark for use in patients with severe, symptomatic aortic stenosis.

Larry Wood, Edwards Lifesciences' corporate vice president for transcatheter heart valves, noted that the "Sapien 3 Ultra system features enhancements on the valve and a new delivery system to address the needs of both patients and clinicians, building on our best-in-class performance of Sapien 3."

Despite gaining clearance in Europe in November, Edwards Lifesciences has not launched the device in Germany after a court there issued a preliminary injunction on future commercial sales of the system that Boston Scientific chose to implement in the country. The court had previously ruled that Edwards Lifesciences' currently available Sapien 3 valve infringed two patents held by Boston Scientific, with a full hearing on the dispute scheduled for mid-2019.

More recently, a jury in the US determined that the Sapien 3 valve infringes a patent held by Boston Scientific, awarding the latter $35 million in damages, as well as further damages and interest incurred that will be determined in post-trial motions. However, Edwards Lifesciences said at the time that it "does not expect to pay the jury award since, earlier this year, the US Patent and Trademark office determined that all asserted claims of the…patent were invalid."

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