The FDA approved the Sapien 3 transcatheter heart valve on Aug. 18 for patients with severe, symptomatic aortic stenosis who are at intermediate risk for open heart surgery.
The Sapien 3 (Edwards Lifesciences) is the first transcatheter aortic valve replacement (TAVR) device approved to treat intermediate risk patients.
In June 2015, the FDA approved the Sapien 3 for high risk patients with severe, symptomatic aortic stenosis.
The expanded approval was based on results of a study that evaluated patients who enrolled in the PARTNER III trial. After one year of treatment, intermediate risk patients who underwent TAVR with the Sapien 3 had clinically significant reductions in the composite primary endpoint of mortality, stroke and moderate or severe aortic regurgitation compared with patients who had surgical valve replacement.
The findings of that trial were presented at the American College of Cardiology scientific session in Chicago in April and simultaneously published online in The Lancet.
With the expanded indication, patients who are deemed to have a predicted risk of surgical mortality of greater than or equal to 3 percent at 30 days would be eligible to undergo TAVR with the Sapien 3.
For the second quarter of 2016, Edwards Lifesciences posted a 71.5 percent sales increase in its transcatheter heart valve therapy division to $246.4 million.