Abbott has collected a green light in Europe for its dissolving, drug-laden stent in peripheral artery disease, following its approval from the FDA early last year.
The company said the CE mark opens up the Esprit BTK scaffold treatment to more than 50 million people on the continent—about twice the population in the U.S.—including people with severe forms of the chronic disease who potentially face amputations of the lower legs and poor survival rates.
Made from a material similar to bioresorbable sutures, the temporary stent holds open the blocked arteries located below the knee while delivering a dose of the immunosuppressant everolimus, which helps keep the vessel from reclosing as it heals.
A previous clinical trial compared the Esprit BTK scaffold to the standard approach of balloon angioplasty, which showed that after one year, 74% of treated patients saw no amputations, completely blocked vessels or the need to redo the procedure, compared to just 44% of participants in the control arm. The stent is designed to be completely absorbed by the body after three years.
Later findings from that study demonstrated that after two years, patients who received the Esprit BTK underwent about half as many procedures to reopen a closed artery versus balloon angioplasty alone.
This particular field has not seen many technical advancements receive regulatory go-aheads until recently. Earlier this summer, the FDA granted a de novo clearance to a retrievable stent system for the lower limbs designed by Reflow Medical. The Spur carries a series of small, retractable spikes that puncture calcifications from within the arteries below-the-knee to help treat chronic limb-threatening ischemia. That device previously received a CE mark in January 2024.