FDA Approves Abbott’s Dissolving Stent for Below-the-Knee Arteries

Abbott has gained U.S. Food and Drug Administration (FDA) approval for its Esprit BTK (below-the-knee) Everolimus eluting resorbable scaffold system (Esprit BTK system).
 
Esprit BTK is a breakthrough device for people with chronic limb-threatening ischemia (CLTI) below-the-knee. It keeps arteries open and delivers the drug Everolimus to support vessel healing, before completely dissolving.
 
According to Abbott, until this approval there were no stents or drug-coated balloons approved for below the knee use. The standard of care was balloon angioplasty, which uses a small balloon delivered by a catheter to the blockage to compress it against the arterial wall. However, blockages treated this way have many instances of reblockage.
 
The Esprit BTK system is made of material similar to dissolving sutures. It’s implanted in a catheter-based procedure via a small incision in the leg. Once the blockage is open, the Esprit BTK scaffold helps health the vessel and provides support for about three years until the vessel is strong enough to stay open on its own.
 
The LIFE-BTK trial, which evaluated Abbott’s Esprit BTK System, was presented in October 2023 as a late-breaking clinical trial at the 35th Transcatheter Cardiovascular Therapeutics (TCT) Conference in San Francisco and simultaneously published in the New England Journal of Medicine. The results of the trial demonstrated Esprit BTK reduces disease progression and helps improve medical outcomes compared to balloon angioplasty.
 
“The FDA approval of Abbott’s Esprit BTK System marks a significant milestone in our fight against peripheral artery disease below the knee and should usher in a new era of improved outcomes for people worldwide,” said Sahil A. Parikh, M.D., Columbia University Irving Medical Center, and one of the principal investigators of the LIFE-BTK trial. “By introducing a treatment option that is superior to balloon angioplasty, Abbott is changing the landscape of CLTI therapy.”
 
“At Abbott, we’ve recognized the significant burden of disease and limited treatment options available for people living with the most severe form of PAD. That’s why we’re revolutionizing treatments with resorbable scaffold technology below the knee,” said Julie Tyler, senior vice president of Abbott’s vascular business. “Our resorbable program is focused on meeting unmet needs in the peripheral anatomy to help people live better and fuller lives.”