You are here

Artificial Heart Valve Wins FDA Nod

Device reduces complications of valve-replacement procedure

The FDA has approved the SAPIEN 3 transcatheter aortic heart valve for the treatment of high-risk patients with severe, symptomatic aortic stenosis.

The decision was based on positive results from a cohort of the PARTNER II (Placement of AoRTic TraNscathetER Valves II) trial, which enrolled 583 high-risk patients at 29 U.S. sites.

“The PARTNER II study concluded that this new valve reduced several complications associated with the TAVR [transcatheter aortic valve replacement] procedure, such as paravalvular leakage and stroke, and represented a meaningful improvement over data from prior studies with earlier-generation devices,” said co-principal investigator Martin B. Leon, MD, professor of medicine at the Columbia University College of Physicians and Surgeons.

The new valve, available in 20-mm, 23-mm, 26-mm, and 29-mm sizes, has an outer skirt (a cuff of fabric surrounding the valve frame), which provides a seal to address paravalvular leakage, according to its manufacturer, Edwards Lifesciences Corporation. The company expects the product’s launch to be largely completed by the end of the year.

The SAPIEN 3 valve has been commercially available in Europe since January 2014.

Source: Edwards Lifesciences Corp.; June 17, 2015.

Recent Headlines

Despite older, sicker patients, mortality rate fell by a third in 10 years
Study finds fewer than half of trials followed the law
WHO to meet tomorrow to decide on international public heath emergency declaration
Study of posted prices finds wild variations and missing data
Potential contamination could lead to supply chain disruptions
Delayed surgery reduces benefits; premature surgery raises risks
Mortality nearly doubled when patients stopped using their drugs
Acasti reports disappointing results for a second Omega-3-based drug
Declining lung cancer mortality helped fuel the progress