Edwards Eyes Delay for its Sapien 3 Ultra TAVR

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. Join us at the BIOMEDevice Boston Expo,  April 18–19, 2018. Use promo code "MDDI" for 20% off conference registration and free expo access.   “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 ...
Source: MDDI - Category: Medical Devices Authors: Tags: Implants Source Type: news