Medtronic's CoreValve Evolut, Edwards Lifesciences' Sapien 3 TAVR systems expanded in US to include low-risk patients

The FDA announced Friday that it expanded the indications for Medtronic's CoreValve Evolut R and CoreValve Evolut PRO transcatheter aortic valve replacement (TAVR) systems, as well as for Edwards Lifesciences' Sapien 3 and Sapien 3 Ultra TAVR systems, to include use in patients with symptomatic severe aortic stenosis at low risk for death or major complications associated with open-heart surgery. The agency noted that it is the first medical products regulatory body in the world to expand the indication for these devices to such patients.

"This new approval significantly expands the number of patients that can be treated with this less invasive procedure for aortic valve replacement and follows a thorough review of data demonstrating these devices are safe and effective for this larger population," commented Bram Zuckerman, director of the Office of Cardiovascular Devices in the FDA's Center for Devices and Radiological Health.

The Medtronic approvals were based on data from the Evolut Low Risk Trial, which evaluated three CoreValve generations, including the Evolut R and Evolut PRO valves. The trial randomised 1403 low-risk patients with severe symptomatic aortic stenosis to undergo TAVR or surgical aortic valve replacement (SAVR). 

The data showed TAVR had an "excellent safety profile" and was an "effective treatment option," resulting in shorter hospital stays and improved quality-of-life scores compared to SAVR, Medtronic said. The Evolut system also demonstrated "superior haemodynamic performance with significantly lower mean aortic valve gradients and larger effective orifice areas compared to surgery...important factors for more active patients," the company noted.

Meanwhile, the expanded approvals for Edwards Lifesciences were supported by data from the PARTNER 3 trial, which randomised 1000 low-risk patients who had severe symptomatic aortic stenosis to undergo either TAVR using the SAPIEN 3 valve or SAVR. Results showed that the SAPIEN 3 system was superior to SAVR, with a 46% reduction in the event rate for the primary endpoint, a composite of all-cause mortality, all stroke and rehospitalisation at one year.

The FDA first approved the CoreValve system in 2014, followed by Evolut R the following year. In 2017, the third-generation Evolut PRO system was approved in the US for patients considered to be at high or extreme risk for open-heart surgery.

Meanwhile, the Sapien 3 valve gained FDA approval in 2015 for patients with aortic valve stenosis who are inoperable or at high risk during open-heart surgery. The indication was later expanded to include certain patients with symptomatic heart disease whose risk of death or severe complications from repeat surgery is high or greater. Last year, the Sapien 3 Ultra system was approved in the US for TAVR in severe, symptomatic aortic stenosis patients who are at intermediate or greater risk during surgery.