Edwards Eyes Delay for its Sapien 3 Ultra TAVR

Edwards Lifesciences plans to submit additional data for the Sapien 3 Ultra valve before it files for CE mark, causing a slight delay in the product getting to the market.

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Edwards Lifesciences said it is delaying the launch of the Sapien 3 Ultra transcatheter aortic valve replacement (TAVR) System in Europe until later this year. The Irvine, CA-based company said it would refocus on commercialization efforts after it submits data from the 30-patient, single-arm study of the device treating patients at intermediate risk from surgical valve replacement. The study data would help supplement the company’s bid to gain CE mark for the technology.

Edwards said the updated timing for the European launch of the Sapien 3 Ultra doesn’t change the company’s sales guidance for 2018 and that it still continues to expect the U.S. introduction of the device in late 2018.

The Sapien 3 Ultra System features an on-balloon design that is intended to streamline procedures, a new skirt design for enhanced sealing, and an ergonomic handle design that is intended to enable single-handled control for the physician.

“We think it's going to help simplify these procedures and reduce the risk of complications and this is not to be underestimated as well,” said Michael Mussallem, chairman and CEO of Edwards, according to a transcript from Seeking Alpha. “We are so pleased with the performance of Sapien 3 already we think Ultra has a chance to even take it to the next level.”

Edwards also announced that enrollment is complete in the CT imaging sub-study within the PARTNER 3 trial of the Sapien 3 valve. This randomized sub-study is examining leaflet mobility of both the SAPIEN 3 valve and surgical heart valves in low-risk patients undergoing valve replacement for the treatment of severe aortic stenosis.

Enrollment in the PARTNER 3 main study of the Sapien 3 valve in low-risk patients was already complete. As previously indicated, Edwards said it continues to anticipate that data from the PARTNER 3 trial will be presented at ACC 2019, and expects to receive FDA approval for the indication late that year.

This is the second TAVR device to be delayed in recent months – although for very different reasons. Earlier this year, Boston Scientific noted it would delay commercialization of its Lotus Edge valve in Europe until 2019.

The Marlborough, MA-based company halted commercial implants of the Lotus Edge in 2016 after a locking issue with one pin of the valve's commisure was observed in seven of roughly 200 commercial implants (4%). Then, the company recalled all of its Lotus valves from the market in February of 2017 after getting reports of a similar mechanical problem with a pin that connects the valve to the delivery system.

 

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