Abbott has announced new positive late-breaking data of its Esprit BTK Everolimus Eluting Resorbable Scaffold System (Esprit BTK) for people with severe peripheral artery disease (PAD) below the knee (BTK).
The Esprit BTK system received approval from the US Food and Drug Administration (FDA) in April for patients suffering from chronic limb-threatening ischemia (CLTI) BTK.
The system is a dissolvable stent designed to keep arteries open while delivering everolimus, which supports vessel healing.
In October 2023, Abbott announced positive results from the LIFE-BTK trial evaluating Esprit BTK in patients having CLTI. The study met both of its primary safety and effectiveness endpoints and outperformed the current standard of care.
The LIFE-BTK trial also assessed whether the Esprit BTK system could provide better long-term outcomes than balloon angioplasty, the current standard treatment for PAD BTK.
The results from the second year of the trial, involving over 260 patients demonstrated the long-term effectiveness of the Esprit BTK system.
After two years, the investigational stent outperformed balloon angioplasty, with fewer repeat procedures. It offered sustained benefits for PAD patients.
The primary efficacy endpoint focused on the system’s ability to keep the vessel open longer and delay the need for further interventions.
The results show that 90.3% of patients treated with the Esprit BTK system did not require re-intervention in the study. The system also reduced reclosures, and helping the vessel to stay open.
Compared to balloon angioplasty, patients treated with the Esprit BTK system had a much higher rate of freedom from CLTI.
Additionally, at one year, the stent showed a 35.2% improvement in reducing vessel re-narrowing compared to balloon angioplasty.
Abbott vascular business global clinical affairs divisional vice president Jennifer Jones-McMeans said: “The positive results at two years reinforce Esprit BTK’s potential to revolutionise the treatment of peripheral artery disease below the knee.
“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.”
Abbott has also launched the Esprit BTK Post-Approval Study (PAS) to evaluate the ongoing safety and effectiveness of the Esprit BTK system in treating CLTI patients with blocked arteries below the knee in a real-world setting.
