Dive Brief:

• Medtronic's Evolut transcatheter aortic valve implantation system now has an expanded CE mark to treat patients with severe aortic stenosis who are at low risk for mortality in traditional open heart surgery, the medtech giant said Monday.
• In addition to being OK'd for that group of low-risk patients, the Evolut platform also garnered approval for a new indication in patients with bicuspid aortic valves who are at intermediate, high and extreme risk for surgical mortality.
• Medtronic estimates the market for bicuspid and tricuspid aortic stenosis patients combined, who are at low risk for surgery, at 320,000 individuals in the U.S., Western Europe and Japan, a company spokesperson told MedTech Dive in an email. The company did not break out a separate figure for bicuspid patients at intermediate risk and above for surgery. Evolut is not yet approved for low-risk patients in Japan but is "actively under review" by regulators, the spokesperson said.

Dive Insight:

A less-invasive, catheter-based approach to valve replacement, Evolut is now indicated in Europe for severe aortic stenosis patients across all risk categories: extreme, high, intermediate and low.

“The low-risk indication marks an important milestone for patients across Europe as TAVI expands into a potentially younger and more active patient population,” cardiac surgeon Thomas Modine, an investigator in the approximately 1,400-patient Evolut Low Risk Trial that supported the CE mark expansion, said in a statement from Medtronic. “Heart teams will have more freedom to choose the best aortic valve replacement procedure based on each patient’s individual characteristics.”

Medtronic's European launch for low-risk patients follows rival Edwards Lifesciences' receipt in November of the CE mark to expand the use of its Sapien 3 transcatheter valve in the low-risk population and comes just as surgeons and device makers are gaining confidence in a rebound of elective procedures after a steep dropoff in April tied to the onset of the COVID-19 pandemic. CEO Geoff Martha told an investor conference earlier this month that a May and June procedure recovery was outpacing the company's expectations.

The CE mark for Evolut includes new labeling that permits treatment of patients with bicuspid aortic valves for patients at extreme, high and intermediate risk of surgical mortality. A bicuspid aortic valve has two leaflets instead of the typical three. The congenital heart defect occurs in 1% to 2% of people, yet bicuspid aortic valve stenosis represents almost 40% of the intermediate- and high-risk symptomatic aortic stenosis patient population, according to Medtronic data.

Both Medtronic and Edwards received FDA expanded indications last August for the use of their transcatheter aortic valve replacement systems in low-risk patients with severe aortic stenosis.

FDA authorization in the low-risk group followed the release of results from two key studies at the American College of Cardiology's annual meeting in March 2019. Edwards' Partner 3 study showed Sapien 3 was superior to conventional surgery, while Medtronic's Evolut Low Risk Trial found TAVR was as good as open surgery.