FDA Expands CoreValve TAVR Indication to Intermediate-Risk Patients

Patrice Wendling

July 10, 2017

DUBLIN, IRELAND — The US Food and Drug Administration today expanded the indication for the CoreValve transcatheter aortic-valve replacement (TAVR) systems to include treatment of patients with severe aortic stenosis at intermediate risk for surgery, according to the company[1].

The new indication covers Medtronic's first-generation CoreValve, next-generation CoreValve Evolut R, and the recently FDA-approved CoreValve Evolut PRO systems.

The FDA decision is based on results from the 1746-patient SURTAVI trial, reported by theheart.org|Medscape Cardiology from the 2017 American College of Cardiology meeting.

The trial met the primary noninferiority end point of all-cause death or disabling stroke, which at 2 years was 12.6% for TAVR and 14.0% for surgical valve replacement (posterior probability of noninferiority >0.999).

Disabling stroke strongly favored TAVR over surgery at 2 years, although surgery was associated with less aortic regurgitation, fewer major vascular complications, and lower need for permanent pacemaker implantation.

The Medtronic statement defines intermediate risk as a 3% or greater risk at 30 days of the procedure, when assessed by a heart team in combination with the Society of Thoracic Surgeons score and other factors such as comorbidities, frailty, prior surgical intervention, and disabilities.

The FDA expanded the TAVR indications for the Sapien XT and Sapien 3 (Edwards Lifesciences) valves for intermediate-risk patients in August 2016.

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