FDA approves Abbott’s resorbable stent for BTK arteries
The U.S. Food and Drug Administration (FDA) has approved Abbott’s new dissolving stent for below the knee (BTK) arteries.
The Espirit BTK Everolimus Eluting Resorbable Scaffold was designed to treat patients with chronic limb-threatening ischemia (CLTI) in their BTK arteries. It opens the artery to deliver a dose of everolimus and then completely dissolves over time once it is no longer needed.
According to Abbott, care teams have not had an effective stent or drug-coated balloon for patients who present with peripheral artery disease (PAD) in their BTK arteries, leaving balloon angioplasty as the only interventional treatment option. The Espirit BTK offering is implanted during a minimally invasive transcatheter procedure, staying in place for approximately three years until it dissolves.
The FDA primarily based its decision on data from LIFE-BTK, an Abbott-funded clinical trial focused on data from 225 patients randomized in a 2:1 ratio to receive treatment with the Espirit BTK System or angioplasty. Initial results from LIFE-BTK were presented at TCT 2023 in San Francisco and published in the New England Journal of Medicine; they suggest the resorbable scaffold was safe and associated with superior patient outcomes.[1]
Click here and here for additional Cardiovascular Business coverage of LIFE-BTK.
“The FDA approval of Abbott's Esprit BTK System marks a significant milestone in our fight against PAD below the knee and should usher in a new era of improved outcomes for people worldwide,” Sahil A. Parikh, MD, an interventional cardiologist with Columbia University Irving Medical Center and a principal investigator of the LIFE-BTK trial, said in a statement. “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,” added Julie Tyler, senior vice president of Abbott's vascular business. “That's why we're revolutionizing treatments with resorbable scaffold technology below the knee. Our resorbable program is focused on meeting unmet needs in the peripheral anatomy to help people live better and fuller lives.”
Something old is new again in bioresorbable stent technology
The Esprit BTK vascular scaffold is a new version of Abbott's previous Absorb bioresorbable coronary stent. The Absorb stent was originally seen as a major advancement in coronary stent technology when it was cleared for commercial sales in Europe in 2011 and the United States in 2016. But long-term data showed it had limitations compared to metal stents. These included poor outcomes in smaller vessels and deliver issues due to the thicker struts, issues with stent recoil, limited ability to over-expand without breaking struts, and a higher price tag than metallic stents, which were easier to use. The Absorb was pulled off the market due to poor sales in September 2017.
However, at the time Abbott said the stent might be revived for peripheral use where placing permanent metallic stents is not ideal. That research culminated in today's approval of the Esprit.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.