After receiving a green light earlier this year from the FDA, Medtronic has now collected a European approval for the latest version of its transcatheter aortic valve replacement implant.
Compared to its predecessors, the Evolut FX+ system has added wider gaps between the struts of its stentlike frame, making it easier for surgeons to thread catheters into the heart’s coronary arteries if a patient requires a subsequent procedure. The company said its diamond-shaped windows are four times larger than the openings in its previous Evolut designs.
The implant’s CE mark covers its use on the continent in patients with aortic valves that have narrowed to the point of causing symptoms such as chest pain and shortness of breath. The company estimates that as many as 50% of patients with untreated disease may die of heart failure within two years.
The approval also includes patients across all risk categories for an open surgical procedure, the same as in the U.S.
“We are excited to complete this momentous milestone and expand our solutions for severe aortic stenosis across Europe,” Jorie Soskin, general manager of Medtronic’s structural heart division, said in a statement. The company said it plans to begin the Evolut FX+ valve’s commercial rollout in Europe within the coming weeks.
Stateside, Medtronic this week also received the FDA’s blessing to conduct a clinical study of its Prevail drug-coated balloon sized for coronary artery disease—including in procedures to reopen already-placed heart stents as well as previously untreated blood vessel blockages.
Medtronic said data from a dual cohort study, set to enroll about 1,200 people, will support regulatory submissions in the U.S. and Japan. One side of the trial will randomize patients needing in-stent restenosis head-to-head against Boston Scientific’s Agent balloon.
Meanwhile, a single-arm portion will focus on Prevail in de novo small vessel disease, and will compare it to an historical control group of patients that have received drug-eluting stents through Medtronic’s prior clinical studies of its Resolute Onyx implant. Participants in both cohorts will be followed for five years.
The paclitaxel-coated Prevail was previously launched in Europe in 2021, and the company said it is commercially available in 79 countries worldwide.
In the U.S., Boston Scientific’s Agent scored the first FDA approval this past spring for a coronary drug-coated balloon for in-stent restenosis, where a previously placed stent has been overtaken by plaque or scar tissue.
In 2023, the agency rolled back its previous warnings of paclitaxel-laden balloons and stents, after a four-year scientific review. The FDA had once recommended alternatives to delivering the chemotherapy drug to blood vessel walls, with the goal of stopping the growth of scar tissue, after it found potential increases in mortality among patients treated for peripheral artery disease. The agency said later studies, including an audit of more than 168,000 Medicare beneficiaries, did not show excess added risks.