Edwards’ Third-Generation Sapien TAVI System Launched In Europe
This article was originally published in The Gray Sheet
Edwards Lifesciences is launching its Sapien 3 transcatheter aortic valve system in Europe following receipt of a CE mark.
You may also be interested in...
Edwards is counting on the Sapien XT valve, which will likely earn FDA approval soon, to compete with Medtronic’s recently approved CoreValve in the U.S, while in Europe the company is working quickly to upgrade customers to Sapien 3.
News Briefs: Medtronic’s CoreValve Approval; J&J Dx Unit Set For Sale; Google’s Glucometer Contact Lens
Medtronic gains FDA approval for its transcather CoreValve system months earlier than predicted. The Carlyle Group makes binding offer for J&J’s Ortho-Clinical Diagnostics business. Google is developing a wireless glucometer embedded within a contact lens. More news briefs.
FDA has approved an investigational device exemption for Edwards Lifesciences’ trial of the Sapien 3 transcatheter aortic valve in intermediate-risk patients. The New England Journal of Medicine publishes results of the STAR trial of Inspire Medical’s upper airway stimulator for treatment of sleep apnea.