New Data Highlights Lasting Benefits of Abbott's Esprit™ BTK System for Peripheral Artery Disease Below the Knee

Abbott has announced new findings from the second year of the LIFE-BTK clinical trial, showcasing the long-term effectiveness of the Esprit™ BTK Everolimus Eluting Resorbable Scaffold System (Esprit BTK) in treating peripheral artery disease (PAD) below the knee. The data, presented at the VIVA 2024 conference, highlighted that patients treated with Esprit BTK required significantly fewer repeat procedures compared to those treated with balloon angioplasty over a two-year period.

Peripheral artery disease (PAD) is a widespread condition affecting one in 20 Americans over the age of 50. In severe cases, it results in blocked vessels that impede blood flow to the lower extremities, causing significant pain, non-healing wounds, and sometimes necessitating limb amputation. Treating PAD below the knee has historically been challenging due to the complex anatomy, leaving patients with limited effective treatment options.

The Esprit BTK System stands out as a first-of-its-kind dissolvable stent designed specifically for PAD below the knee. This system is crafted from a material similar to dissolving sutures, which aids in healing the vessel after opening the blockage and provides support until the vessel can remain open independently.

The LIFE-BTK trial, which evaluated more than 260 patients globally, demonstrated that the Esprit BTK System offers substantial benefits over traditional balloon angioplasty, which is the current standard treatment for PAD below the knee. Balloon angioplasty often results in the vessels becoming re-blocked, necessitating further interventions. The Esprit BTK System, however, significantly reduced the need for additional procedures over a two-year period.

Dr. Brian DeRubertis, a principal investigator in the trial, emphasized the complexity of PAD and the limited treatment options available. He noted that the Esprit BTK System provides a promising new option for those with severe PAD, potentially aiding in restoring blood flow and preventing limb amputation.

Key results from the LIFE-BTK trial over two years include:
- 90.3% of patients treated with Esprit BTK did not require reintervention at 24 months.
- The system maintained efficacy at 24 months by reducing the recurrence of blockages and promoting vessel patency.
- Patients treated with Esprit BTK experienced significantly greater freedom from chronic limb-threatening ischemia compared to those treated with balloon angioplasty (61.5% vs. 32.8%).
- At one year, Esprit BTK showed a 35.2% improvement in reducing vessel re-narrowing compared to balloon angioplasty.

Jennifer Jones-McMeans, divisional vice president of global clinical affairs at Abbott’s vascular business, hailed the positive two-year results as a reinforcement of Esprit BTK's potential to transform PAD treatment below the knee. She highlighted Abbott's commitment to developing innovative treatments that could reduce the need for multiple interventions and, in some instances, avert amputations, thus improving patients' quality of life.

Additionally, Abbott initiated the Esprit BTK Post-Approval Study (PAS) to further evaluate the safety and effectiveness of the Esprit BTK in a real-world setting, particularly in patients with chronic limb-threatening ischemia (CLTI). The first patient in this study was enrolled by Dr. Bernardino L. Rocha, a vascular surgeon in Oklahoma City.

Abbott continues to emphasize its commitment to enhancing the lives of people with PAD and CLTI through ongoing education and innovative medical solutions.