Esprit features materials similar to dissolving sutures. Unlike metal stents, it’s not a permanent implant, providing support for blocked vessels only for a few months after the blockage is cleared. At that point, the vessel can remain open on its own, while the scaffold dissolves.
Esprit BTK offers an alternative to balloon angioplasty, which relies on a small balloon delivered via a catheter. It compresses against the arterial wall, opening the blood vessel and restoring flow. Abbott says that before its FDA approval, no stents or drug-coated balloons treated below-the-knee chronic limb-threatening ischemia in the U.S.
In addition to FDA clearance in April 2024, then CE mark approval in August 2025, Abbott earned a significant reimbursement win for Esprit BTK last month.
Results from the Esprit BTK post-approval study (PAS) were presented at the Charing Cross Symposium in London. They backed Esprit as a safe, effective approach in patients with very challenging critical limb-threatening ischemia (CLTI) and complex lesions.
Findings follow the company’s positive LIFE-BTK trial, evaluating CLTI patients treated with Esprit to prevent artery re-closure.
At 30 days post-treatment, interim PAS data from 200 subjects demonstrated positive results, Abbott said. It reported that all patients were free from reintervention, defined as clinically-driven target lesion revascularization. Esprit also produced a high safety profile comparable to that seen in LIFE-BTK. Investigators reported 2.6% for the composite endpoint of major adverse limb events and peri-operative death. That included 1% above-ankle amputation, which was not related to the device.
Abbott said that physicians successfully treated longer target lesions with an average length of 69.6 ± 61.4 mm (range: 5.0 mm to 400 mm). Lesions in the LIFE-BTK trial registered at an average length of 52.8 ± 41.9 mm (range: 2.0 mm to 170 mm).
Physicians also treated more advanced calcifications. Sites reported the categorization of 39.7% of lesions as moderate and 19.2% as severe. In LIFE-BTK, those tallies came in at 27.7% and 3%, respectively.
Commentary from Abbott officials and investigators
Dr. Ethan Korngold, Abbott chief medical officer, said:
“The initial results from the Esprit BTK Post-Approval Study are highly encouraging, further validating our technology in the real world. These data, especially the consistent performance observed in challenging patients with more advanced disease and complex lesions, reinforce our belief that Esprit BTK is a critical tool in the fight against CLTI. Esprit BTK performs well in the real world: in calcified lesions, long lesions, chronic total occlusions, and in conjunction with advanced vessel prep. It’s an important step toward expanding options for those most at risk of amputation and improving lives.”
Ramon Varcoe, professor of srugery and academic lead at University of New South Wales, said:
“The initial 30-day results from the Esprit BTK Post-Approval Study demonstrate how beneficial the Esprit BTK System could be to help reduce amputations and improve the lives of those most at risk. We’re seeing early evidence that Esprit BTK can deliver the same robust safety and efficacy observed in LIFE-BTK, even when tackling sicker patients with longer, more complex calcified lesions. While these are still early results, it opens the possibility that the Esprit BTK System could be beneficial for those with more severe wounds, end-stage renal disease, and diverse populations who are at risk of amputation.”
