The everolimus-eluting resorbable scaffold system treats chronic limb-threatening ischemia (CLTI) below the knee (BTK). Abbott designed it to keep arteries open and deliver everolimus to support vessel healing prior to completely dissolving. The first-of-its-kind stent provides support to the vessel until it’s strong enough to remain open on its own.
Esprit picked up FDA clearance in April.
Abbott’s LIFE-BTK evaluated Esprit in the treatment of patients with the most severe form of peripheral artery disease (PAD) BTK. The company reported two-year data looking at more than 260 people worldwide at VIVA 2024 in Las Vegas.
LIFE-BTK evaluated whether Esprit BTK could offer greater long-term benefits than balloon angioplasty, a common treatment for PAD. Outcomes showed sustained benefits for Esprit BTK over balloon angioplasty, the standard of care. Investigators also reported fewer repeat procedures at two years.
Abbott said the data also showcased strong two-year results when compared to other therapies. Its primary efficacy endpoint looked at the ability of the vessel to stay open and lengthen the time until another intervention is needed.
In total, 90.3% of patients in the Esprit BTK arm did not require a reintervention at 24 months. The study showed sustained efficacy at 24 months, demonstrating long-term durability in reducing reclosures and helping the vessel stay open.
Compared to balloon angioplasty, those treated with Esprit BTK had significantly greater freedom from CLTI, a severe form of PAD. This represented the primary efficacy clinical event, with the Esprit group registering a freedom rate of 61.5% vs. 32.8%. At one year, the trial’s powered secondary endpoints revealed that Esprit BTK had a higher rate of reducing vessel re-narrowing (35.2% improvement).
Abbott also launched a post-approval study for Esprit BTK to evaluate its continued safety and effectiveness in a real-world setting. Dr. Bernardino L. Rocha, a ascular surgeon at SSM Health Heart & Vascular Care in Oklahoma City, Oklahoma, enrolled the first patient.
“The positive results at two years reinforce Esprit BTK’s potential to revolutionize the treatment of peripheral artery disease below the knee,” said Jennifer Jones-McMeans, DVP of global clinical affairs at Abbott’s vascular business. “We’re proud to be at the forefront of developing innovative treatment options for the millions of people living with PAD. By eliminating the need for multiple interventions and in some cases, amputation, we’re ultimately helping people live fuller, better lives.”
