Abbott (NYSE: ABT) said Health Canada authorized its Esprit BTK Everolimus Eluting Resorbable Scaffold System, a dissolving stent for patients with chronic limb-threatening ischemia (CLTI) below the knee.
The Esprit BTK system is implanted through a catheter-based procedure and is made of material similar to dissolving sutures. The device supports the artery and delivers everolimus to aid vessel healing for about three years before dissolving. Abbott said the approach addresses limitations of balloon angioplasty, the current standard of care, which often results in re-narrowed vessels and repeat procedures.
Clinical results from the LIFE-BTK trial showed the device reduced repeat procedures by 48% compared to balloon angioplasty at two years.
Abbott Vascular’s CMO Dr. Ethan Korngold will share how AI is shaping Abbott’s cardiovascular portfolio at DeviceTalks West, Oct. 15–16, 2025 in Santa Clara, California. Register at West.DeviceTalks.com.
“Health Canada’s approval of Abbott’s Esprit BTK System marks a significant milestone in our fight against peripheral artery disease below-the-knee and represents a new era of improved outcomes for people worldwide,” said Dr. Brian DeRubertis of New York Presbyterian-Weill Cornell Medical Center, a principal investigator of the trial. “Abbott is changing the landscape of CLTI therapy by introducing a treatment option that is superior to balloon angioplasty.”
CLTI is a severe form of peripheral artery disease that affects blood flow to the lower leg and foot. Abbott said more than 800,000 Canadians live with the condition, which can cause extreme pain, non-healing wounds, and, in many cases, lead to amputation.
“At Abbott, we’ve recognized the significant burden of disease and limited treatment options for people living with the most severe form of PAD – treatments that typically include high-risk surgery or less invasive options that come with limitations,” senior vice president of Abbott’s vascular business Julie Tyler said. “Our revolutionary below-the-knee resorbable scaffold technology meets an unmet need that will ultimately help people with PAD live better and fuller lives.”
Abbott won CE mark for Espirit BTK in August, and picked up FDA clearance in April 2024. Last fall, Abbott reported positive LIFE-BTK study outcomes for the system compared to balloon angioplasty.
