Abbott Announces Two-Year Clinical Data from LIFE-BTK Trial Demonstrating Esprit BTK Bioresorbable Scaffold’s Superiority Over PTA in CLTI Patients

Nov 06, 2024 22:15 CST Updated 22:15

Abbott

Diagnostic and pharmaceutical product manufacturers

Abbott Announces Its Bioresorbable ScaffoldEsprit BTKTwo-Year Postoperative Clinical Data (LIFE-BTK), Study Data ConfirmsEsprit BTKDemonstrates long-term effectiveness in treating patients with the most severe peripheral artery disease (PAD) below the knee.

LIFE-BTK is a multicenter randomized controlled clinical study, in which a total of 261 patients with CLTI and infrapopliteal artery disease were randomly assigned at a ratio of 2:1 to receiveEsprit BTK (Experimental Group)or angioplasty (control group) treatment. The primary efficacy endpoint was the absence of above-ankle amputation of the target limb, target vessel occlusion, clinically-driven target lesion revascularization, and binary restenosis of the target lesion within one year. The primary safety endpoint was freedom from major adverse limb events and perioperative death at 6 months.

Specific Research Data

At 24 months post-procedure, 90.3% of patients in the Esprit BTK group did not require reintervention.

At 24 months post-operation, it showedEsprit BTK Treatment Persistence, indicating that the long-term durability of Esprit BTK can effectively reduce vascular stenosis (or embolism) and promote sustained vessel patency.
At 24 months post-operation, no occurrences were observed in either the experimental group or the control group.The probability of chronic limb-threatening ischemia is61.5% and 32.8%, the experimental group was significantly better than the control group;

One Year Post-Operatively, secondary endpoints showed that the trial group had a higher rate of reducing vascular restenosis compared to the control group (35.2% improvement).

PI Evaluation

"PAD is a dangerous disease that is complex to treat, with limited approved treatment options. Abbott's Esprit BTK offers a new option for treating the most severe PAD patients, helping to restore blood flow and potentially save limbs."

---Brian DeRubertis New York Presbyterian-Weill Cornell Medical Center

Executive Evaluation

"The positive results over two years have strengthened Esprit BTK's potential to revolutionize the treatment of below-the-knee peripheral artery disease. We are proud to be at the forefront of developing innovative treatment options for millions of PAD patients. By eliminating the need for multiple interventions, and in some cases even amputation, we ultimately help people lead fuller, better lives."

---Jennifer Jones McMeans, Vice President of Global Clinical Affairs, Abbott Vascular

To further confirm the sustained effectiveness and safety of the Esprit BTK in treating patients with chronic limb-threatening ischemia (CLTI) due to below-the-knee arterial occlusions, Abbott has initiated a post-approval clinical study and completed the enrollment of the first patient.

Esprit BTK

Esprit BTKIt is a product developed based on the technology of the previous generation of bioresorbable coronary stent --- Absorb BVS.Esprit BTKIncluding absorbable stents and delivery systems, its core technology — the absorbable stent — is made from poly-L-lactic acid (PLLA). PLLA is a semi-crystalline bioabsorbable polymer that can resist vascular recoil and provide a platform for drug delivery. The stent wall thickness is only 99μm, and the surface of the stent is evenly coated with poly-D,L-lactic acid (PDLLA) and the cytostatic drug everolimus. PDLLA is an amorphous bioabsorbable polymer coating used for controlled drug release. Everolimus is a drug that inhibits cell proliferation, which can reduce the affected area.The growth of endothelial tissue, preventing vascular occlusion.

Esprit BTK can provide approximately three years of support in the blood vessel until the vessel is strong enough to remain open on its own.Esprit BTK is completely degraded after 48 months, similar to absorbable sutures.

The absorbable stent has two platinum markers at the distal and proximal ends, respectively, for precise positioning.

Esprit BTKDemonstration

Abbott

Abbott, as a global leader in the healthcare industry, helps people live better at all stages of life. We bring cutting-edge technology to health, with leading products across diagnostics, medical devices, nutrition, and pharmaceuticals. Abbott's 109,000 employees worldwide empower people in more than 160 countries and regions to live their best lives.