Edwards Lifesciences (Irvine, CA) won an important approval from the FDA to make the company’s two transcatheter heart valves be available for many patients who are not at extreme mortal threat from open heart surgery or serious post-op complications.
According to the FDA, the valves are now indicated for patients at “intermediate risk of death”, specifically those “at greater than three percent risk of dying within 30 days following surgery,” making these the first valves on the market with such a broad indication.
The news is certainly a big deal for the whole transcatheter valve industry, as it’s proof that the technology will soon be a regularly preferred option over many open procedures.
Here are some details of the study that led to the latest approval, according to the FDA:
In a clinical study to evaluate safety and effectiveness, 1,011 aortic stenosis patients at intermediate risk for surgical complications were randomly selected to have a transcatheter aortic valve replacement procedure using the Sapien XT valve and 1,021 were randomly selected to have a traditional aortic valve replacement during open-heart surgery using a surgical tissue valve. In a second study, 1,078 intermediate risk patients were implanted with the Sapien 3 valve; and outcomes in these patients were compared to the same group of 1,021 surgical control patients in the first study. The two studies demonstrated a reasonable assurance of safety and effectiveness of the Sapien XT and Sapien 3 devices in intermediate risk patients.