FDA News

Newest-generation self-expanding TAVR device receives FDA approval

Medtronic announced the FDA approved a new version of its self-expanding transcatheter aortic valve replacement system designed to improve valve sealing performance.

The valve (CoreValve Evolut PRO) is indicated for treating severe aortic stenosis in patients at high or extreme risk for open-heart surgery, according to a press release issued by the company.

The device has an outer wrap that increases surface area contact between the valve and the native aortic annulus, designed to improve the seal and reduce paravalvular leak, according to the release.

At the American College of Cardiology Scientific Session, researchers presented the results of the Evolut PRO Clinical Study in 60 patients. At 30 days, survival was 98.3%, disabling stroke occurred in 1.7% of patients, mean aortic valve area was 2 cm2 and mean gradient was 6.4 mm Hg, according to the release. In addition, the company stated, 72.4% of patients had no or trace paravalvular leak, no patients had moderate or severe paravalvular leak and the rate of new pacemaker implantation was 10%.

“The big advantage of [the new device] is the way it was modified with the pericardial wrap,” Mathew Williams, MD, chief of adult cardiac surgery and director of the interventional cardiology and heart valve program at NYU Langone Medical Center, said in an interview with Cardiology Today’s Intervention. “The paravalvular leak rate dropped significantly and we had no patients with moderate or worse [paravalvular leak]. In fact, the overwhelming majority had none or trace [paravalvular leak]. There is also a suggestion of a lower pacemaker rate. With 60 patients, we can’t conclude that at this point, but it’s certainly a very positive sign.”

The implantation procedure is almost identical to that of previous generations of the self-expanding TAVR system, Williams told Cardiology Today’s Intervention. “It looks the same on fluoroscopy and [echocardiography]. The difference is … we see almost immediate absence of paravalvular leak.” 

Disclosure: Williams reports receiving research grants from Edwards Lifesciences and Medtronic and consultant fees/honoraria from Abbott Vascular and Edwards Lifesciences.

Medtronic announced the FDA approved a new version of its self-expanding transcatheter aortic valve replacement system designed to improve valve sealing performance.

The valve (CoreValve Evolut PRO) is indicated for treating severe aortic stenosis in patients at high or extreme risk for open-heart surgery, according to a press release issued by the company.

The device has an outer wrap that increases surface area contact between the valve and the native aortic annulus, designed to improve the seal and reduce paravalvular leak, according to the release.

At the American College of Cardiology Scientific Session, researchers presented the results of the Evolut PRO Clinical Study in 60 patients. At 30 days, survival was 98.3%, disabling stroke occurred in 1.7% of patients, mean aortic valve area was 2 cm2 and mean gradient was 6.4 mm Hg, according to the release. In addition, the company stated, 72.4% of patients had no or trace paravalvular leak, no patients had moderate or severe paravalvular leak and the rate of new pacemaker implantation was 10%.

“The big advantage of [the new device] is the way it was modified with the pericardial wrap,” Mathew Williams, MD, chief of adult cardiac surgery and director of the interventional cardiology and heart valve program at NYU Langone Medical Center, said in an interview with Cardiology Today’s Intervention. “The paravalvular leak rate dropped significantly and we had no patients with moderate or worse [paravalvular leak]. In fact, the overwhelming majority had none or trace [paravalvular leak]. There is also a suggestion of a lower pacemaker rate. With 60 patients, we can’t conclude that at this point, but it’s certainly a very positive sign.”

The implantation procedure is almost identical to that of previous generations of the self-expanding TAVR system, Williams told Cardiology Today’s Intervention. “It looks the same on fluoroscopy and [echocardiography]. The difference is … we see almost immediate absence of paravalvular leak.” 

Disclosure: Williams reports receiving research grants from Edwards Lifesciences and Medtronic and consultant fees/honoraria from Abbott Vascular and Edwards Lifesciences.