FDA Expands CoreValve Indication to Include Intermediate-Risk Patients

The US Food and Drug Administration (FDA) has approved an expanded indication for the CoreValve series of transcatheter aortic valve replacement systems to include patients with symptomatic severe aortic stenosis at intermediate risk for surgery, the company announced today.

The expanded indication includes the first-generation CoreValve as well as the next-generation Evolut R and Evolut PRO systems, all manufactured by Medtronic.

The regulatory decision is based on data from SURTAVI. As reported by TCTMD, the 2-year rate of all-cause death or disabling stroke in SURTAVI was 12.6% in patients who underwent TAVR with either the first-generation CoreValve prosthesis or next-generation Evolut R and 14.0% with surgery, a difference that met criteria for noninferiority.

Back in August 2016, the FDA expanded the indication for the Sapien XT and Sapien 3 (Edwards Lifesciences) devices to include intermediate-risk patients.

In March 2017, the American Heart Association and American College of Cardiology updated their guidelines for valvular heart disease to include a class IIa recommendation supporting the use of TAVR is a reasonable alternative to surgery in the intermediate-risk population. Some experts are already calling for that recommendation to be updated to Class I, in the wake of the SURTAVI results.

“Intermediate” risk, according to a statement from Medtronic, is defined as a 3% or greater risk of death within 30 days following the procedure, as determined by the heart team in combination with the Society of Thoracic Surgeons (STS) score and other factors, such as comorbidities, frailty, prior surgical intervention, and disabilities.