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FDA grants expanded patient population to self-expanding TAVR system

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Medtronic announced that the FDA revised the instructions for use labeling of its self-expanding transcatheter aortic valve replacement system.

The system (CoreValve, Medtronic) is now authorized for use in patients with end-stage renal disease or low flow, low gradient aortic stenosis. TAVR had not been endorsed in those patients because of severe comorbidities, according to a press release issued by Medtronic.

“This is a significant opportunity, as many of these patients were not previously receiving TAVR because of severe comorbidities,” Daniel P. O’Hair, MD, director of interventional cardiac surgery at St. Luke’s Medical Center, Milwaukee, and an investigator in the CoreValve U.S. Expanded Use Study, told Cardiology Today’s Intervention. “Despite the clinical challenges faced by these patients, robust clinical data show that when these patients are treated with the CoreValve system, they live longer and are able to achieve and maintain a dramatic improvement in quality of life.”

The decision was based on results from the CoreValve U.S. Expanded Use Study presented in October at Transcatheter Cardiovascular Therapeutics, according to the release. According to the presentation, at 1 year, patients with end-stage renal disease or low flow, low gradient aortic stenosis showed improved quality of life from baseline (P < .001 for both); had mortality rates of 23.1% in the low flow, low gradient aortic stenosis group and 32.7% in the end-stage renal disease group; and had stroke rates of 4.9% in the low flow, low gradient aortic stenosis group and 1% in the end-stage renal disease group.

According to the release, these figures are comparable to those seen in the CoreValve U.S. Pivotal Extreme Risk trial.

“I believe physicians will use TAVR for patients with [low flow, low gradient aortic stenosis] and [end-stage renal disease] immediately, as it has become a standard of care in these unique patient populations,” O’Hair said in an interview, adding that these patients “have added risk with surgical AVR, and therefore TAVR is a great treatment solution.” – by Erik Swain

Disclosure: O’Hair reports financial ties with Medtronic.