CardioExchange Archive

CardioExchange, an NEJM practice community for medical professionals dedicated to improving cardiac patient care, was active from 2009 to 2015. CardioExchange fostered discussion between clinicians from across the globe.

June 13th, 2014

CoreValve Gains New Indication for High-Risk Patients

Medtronic’s CoreValve system today gained a second indication from the FDA for use in patients with severe aortic stenosis who are at high risk for surgery. The transcatheter aortic valve replacement (TAVR) system was initially approved earlier this year for use in patients who were  too ill or frail for traditional open heart surgery.

The new approval is based on results from the U.S. CoreValve High-Risk Study published in the New England Journal of Medicine. In the trial, 795 patients with severe aortic stenosis who who were at high risk for surgery were randomized to surgical aortic valve replacement (SAVR) or CoreValve. At 1 year the rate of death was 14.2% in the TAVR group versus 19.1% in the SAVR group, a difference that was highly significant for noninferiority (P<0.001) and even reached significance for superiority (P=0.04).

Medtronic said that the FDA had approved the entire CoreValve platform (23 mm, 26 mm, 29 mm and 31 mm size valves) — all of which are delivered through the smallest commercially available TAVR delivery system.

“This rigorous trial has defined a new standard for transcatheter valve performance, with superiority results that give physicians even more confidence in making TAVR treatment decisions,” said David Adams, co-principal investigator of the trial, in a Medtronic press release. “With this approval, we can treat more patients due to the broad range of CoreValve sizes, and we have an option compared to surgery that provides a greater chance for a longer life while minimizing the risk of stroke.”

After a somewhat slow start the TAVR market now appears poised for greater growth. In addition to the new CoreValve indication, Edwards’ second generation TAVR system is expected to gain approval soon. Further, the recent settlement of a seemingly endless series of patent disputes between Medtronic and Edwards should allow the companies to focus on medical issues without worrying about legal threats.

 

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