Edwards Lifesciences (NYSE:EW) today unveiled the 1st clinical data on its next-generation Sapien 3 transcatheter aortic valve implantation system, just as the company exited a massive TAVI patent war with arch-rival Medtronic (NYSE:MDT).
Investigators evaluated the Sapien 3 device in 150 patients deemed at ‘high’ or ‘intermediate’ risk for traditional open surgery to replace worn out heart valves. At 30 days researchers saw a 2.1% rate of mortality associated with the implantation surgery and a stroke rate of 1%. About 96.6% of patients had mild or less valve leakage, with no instances of severe paravalvular leak, according to the company.
"The Edwards Sapien 3 valve sets a new standard for tissue valves, combining a low-profile design with the ability to address paravalvular leak, as well as improved delivery systems," Edwards transcatheter heart valves corporate vice president Larry Wood said in prepared remarks. "It is particularly encouraging that these early results showed that none of the patients were re-hospitalized during the follow-up period, which is a meaningful outcome for patients who had previously been very ill."
The Sapien 3 valve, designed in part to address some of the concerns about leakage in earlier generations of valves, has been on the European market since approval in January 2014. The device is approved only for investigational use in the U.S. and is under evaluation in the PARTNER II clinical trial.
Edwards released news of its next-generation valve just as the company announced a wide-ranging TAVI patent agreement with long-time rival Medtronic. The companies announced this morning that they put to rest their international patent infringement war in a deal that will see Medtronic pay royalties through April 2022 of at least $40 million annually, in addition to a $750 million one-time payment.
Neither company admitted to any infringement as part of the settlement.