logo
  

Medtronic Canada Receives Expanded Indication From Health Canada For Evolut TAVI Platform

Medtronic Canada ULC, a unit of Medtronic plc (MDT), has received a new expanded indication from Health Canada for Evolut Transcatheter Aortic Valve Implantation system. The company noted that its TAVI platform is currently the only system licensed for both bicuspid aortic valves, as well as all surgical risk categories in Canada. The expanded indication also allows patients with bicuspid aortic valves at extreme, high and intermediate risk of surgical mortality to also receive the procedure.

The expanded indication was based on clinical data from the global, randomized, multi-center Evolut Low Risk Trial, which evaluated three valve generations against surgical valve replacement in more than 1,400 patients.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
The U.S. Food and Drug Administration said it now intends to review only a small subset of new emergency use authorization or EUA requests for diagnostic tests. As per an updated COVID-19 test policy with a view to ensure continued access to tests, the regulator further urged developers of all test types seeking marketing authorization to pursue traditional premarket review for most test types. Netflix, Inc. said it is adding a new feature to offer a more personalized mobile games experience on the platform. In a statement, Sophia Yang, Product Manager, Mobile Games, said the company is rolling out the ability to create game handles, with which members will be able to create a unique public username. This can be used across all Netflix games. General Motors Co. has delayed its plan to require employees to return to office many days a week until next year, reports said citing an internal memo signed by CEO Mary Barra. Last week, the company had announced that corporate workers would be required to return to respective offices at least three days a week, beginning later this year, as the COVID-19 pandemic eases.
Follow RTT