The U.S. Food and Drug Administration has expanded the approval of Edwards Lifesciences Corp.'s Sapien 3 and Sapien 3 Ultra along with Medtronic PLC's CoreValve Evolut R and CoreValve Evolut PRO transcatheter heart valves to treat patients with aortic stenosis who are at low risk of open-heart surgery.
Aortic stenosis is a heart condition in which the patient's aortic valve narrows and does not open fully, causing a reduction or blockage in blood flow from the heart to the main artery. The procedure for inserting a transcatheter heart valve is less invasive and requires a shorter recovery time compared to open-heart surgery.
These devices were approved under the FDA's premarket approval pathway. The approval is based on results from late-stage trials that compared the effectiveness of transcatheter valves with traditional open-heart surgery in patients with severe symptomatic aortic stenosis who were deemed to be at low risk of death from surgery.
The Partner 3 study for Sapien 3 showed that low-risk patients treated with the valves saw 1% rates of death or disabling stroke at one year, a short length of stay and 96% rate of patients discharged to home or self-care.
Medtronic's Evolut Low Risk Trial showed that patients treated with transcatheter valves had lower rates of heart failure hospitalizations and disabling stroke compared to the surgery group after 12 months. The risk of death, stroke and rehospitalization after one year for patients who received Sapien 3 valves was at 8.5%, versus 15.1% for the surgery patient group.
The U.S. regulator approved CoreValve Evolut PRO valve for patients at high or extreme risk of open-heart surgery in March 2017 and the Sapien 3 Ultra system in high-risk patients in December 2018.
Under the approval, the device manufacturers are required by the FDA to follow patients enrolled in the trials for 10 years to monitor safety and effectiveness, including the long-term durability of these devices.