Abbott’s Esprit Below-the-Knee Dissolving Stent Earns CE Mark

Abbott has received CE mark approval for its Esprit BTK (below the knee) everolimus eluting resorbable scaffold system (Esprit BTK system).

Esprit BTK is a new technology for people with peripheral artery disease (PAD) below the knee. It’s designed to keep arteries open and deliver everolimus to support vessel healing before completely dissolving over time.

It’s the first resorbable scaffold of its kind for use below the knee, according to Abbott. Made of a material similar to dissolving sutures, the stent is implanted through a minimally invasive, catheter-based procedure via a small incision in the leg. Once the blockage is cleared, Esprit BTK helps heal the vessel and offer support until the vessel can stay open on its own, after which the scaffold dissolves.

Professor Dierk Scheinert, M.D., University Hospital Leipzig and Head of the Department Angiology said for too long patients with severe PAD below the knee had limited treatment options and were often faced with possible amputations.

“With CE Mark, the Esprit BTK System offers a resorbable scaffold backed by strong data and proven superiority over balloon angioplasty—giving physicians a novel, innovative tool to treat the most severe forms of PAD more effectively and improve patient outcomes across Europe,” Dr. Scheinert told the press.

The Esprit BTK system earned U.S. Food and Drug Administration (FDA) approval in April 2024.

“Abbott is an expert in the development of innovative treatments for vascular diseases, and pioneered dissolving stents for people with PAD below the knee,” said Samih Al Mawass, divisional vice president of Europe, Middle East & Africa (EMEA) at Abbott’s vascular business. “With the Esprit BTK System, we’re helping to restore blood flow without leaving a permanent implant behind. Our resorbable program is focused on delivering meaningful innovation in the peripheral anatomy to help patients live healthier, fuller lives.”