The Food and Drug Administration concluded that the new heart valve has less leakage than its predecessor, though patients still face a risk of serious complications from implantation, including death, stroke and heart attack. Patients who can’t tolerate anticoagulation treatment shouldn’t use the valve, the agency said Wednesday in a statement.
Edwards, based in Irvine, California, sold $826 million worth of heart valves that can be inserted without
The valves are placed inside the heart after being threaded up through a large artery. Over the years, they’ve gotten smaller and easier for surgeons to use. They can replace a faulty valve that otherwise would have to be operated on via
The products are designed to help people with aortic stenosis, a narrowing of the valve between the left ventricle and the aorta that can cause blood to back up in the heart, leading to chest pain and breathlessness. More than 250,000 people around the world have severe, symptomatic aortic stenosis.
Sapien 3 is already sold in Europe, after being approved there last year.