Abbott’s Longer Length Esprit BTK Drug-Eluting Scaffold Gets FDA OK

Abbott announced that it’s received U.S. Food and Drug Administration (FDA) approval for a longer length of its Esprit BTK (below-the-knee) drug-eluting stent system to treat chronic limb-threatening ischemia (CLTI).

The newly approved 76 mm system aims to help physicians treat lesions using fewer devices. Most below-the-knee lesions in CLTI patients are longer than 100 mm and existing lengths can require multiple Esprit BTK scaffolds.

CLTI can cause extreme pain, wounds that fail to heal, and in severe cases, amputation. It’s associated with poor long-term outcomes and has a 50% mortality rate over a five-year period after diagnosis.

“The FDA approval of the Abbott longer-length Esprit BTK scaffold represents an important advancement for physicians treating patients with chronic limb-threatening ischemia,” said Ethan Korngold, MD, chief medical officer of Abbott’s vascular business. “By enabling treatment of longer lesions with fewer devices, this new option can help simplify procedures, improve workflow efficiency, and support more consistent treatment. Building on the proven performance of our Esprit platform, we remain focused on delivering meaningful innovations that address real-world challenges and help physicians improve patient care.”

Esprit Long Length is based on the Esprit BTK scaffold design and over-the-wire platform. The dissolvable, resorbing scaffold is the first of its kind on the market with robust long-term clinical evidence, Abbott claims.

In the past two years, the Esprit BTK everolimus-eluting resorbable scaffold system has earned regulatory approval in the U.S., Europe, and Canada.