FDAnews Device Daily Bulletin
Medical Devices / Research and Development

Medtronic’s CoreValve Bests Surgery at Two-Year Mark

March 17, 2015

Medtronic said Sunday that data from a U.S. pivotal trial showed patients who underwent transcatheter aortic valve replacement using CoreValve had a higher two-year survival rate than those who had their valves surgically replaced. The difference in all-cause mortality between the two groups jumped from 4.8 percent at one year to 6.5 percent at the end of the second year.

Patients in the TAVR arm also had a lower stroke rate than those in the control group — 10.9 percent versus 16.6 percent.

The multicenter clinical trial randomized 747 patients with advanced forms of aortic stenosis to with TAVR or open-heart surgery. The patients had an estimated mortality risk of 15 percent or greater at 30 days and preexisting surgical risk factors such as frailty and disability.

The FDA approved the CoreValve system last year for patients in need of aortic valve replacement who are at high or severe risk for surgery. The device is also available in countries that recognize the CE mark. — Jason Scott