Tag: CoreValve

FDA approves Evolut PRO+

The US Food and Drug Administration (FDA) has approved the Evolut PRO+ transcatheter aortic valve implantation (TAVI) system, which a press release states builds...

FDA approves Sapien 3 Ultra, Sapien 3, and CoreValve for low-risk...

On 16 August, the US Food and Drug Administration (FDA) approved Edwards Lifesciences’ Sapien 3 and Sapien 3 Ultra and Medtronic’s Evolut R and...

TCT 2018: Longest-term data to date for CoreValve study show excellent...

New data presented at 2018 Transcatheter Cardiovascular Therapeutics (TCT) meeting (21–25 September, San Diego, USA), according to a press release, patients implanted with the...

ACC 2018: Five-year data for CoreValve show strong haemodynamic performance

New data from the CoreValve US Pivotal Extreme Risk Study and the real-world NOTION trial (Nordic aortic valve intervention Trial)—both of which examined patients...

EuroPCR 2017: Study provides “first step” towards showing long-term durability of...

New data presented, by Luca Testa (Department of Cardiology, IRCCS Policlinico S. Donato, Milan, Italy), at EuroPCR (16–19 May, Paris, France) indicates that there...

EuroPCR 2017: Excellent clinical outcomes for Medtronic’s CoreValve and Evolut systems...

New positive data on the self-expanding Medtronic CoreValve platform from the CoreValve ADVANCE and Evolut R FORWARD clinical studies—two large, rigorous global registries—have been...

TAVI pacemaker issue is “an engineering problem that will be solved”

The SURTAVI trial indicates that transcatheter aortic valve implantation (TAVI)  with CoreValve/CoreValve Evolut R (Medtronic) is non-inferior to surgery for the management of severe...

ACC 2017: FDA approves launch of CoreValve Evolut Pro

The FDA has approved Medtronic’s CoreValve Evolut Pro transcatheter aortic valve implantation (TAVI) device. This approval follows data for the device that were presented...

ACC 2017: CoreValve non-inferior to surgery in intermediate-risk patients

Results from the SURTAVI clinical trial, which were presented today at the 2017 scientific sessions of the American College of Cardiology (17–19 March, Washington,...

Japan’s Ministry of Health, Labor and Welfare approves reimbursement for Medtronic’s...

Medtronic has been granted reimbursement approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for its recapturable, self-expanding transcatheter CoreValve Evolut R...