The LIFE-BTK trial is designed to evaluate Abbott’s new drug-eluting resorbable scaffold (DRS), for the treatment of blocked arteries below-the-knee (BTK)
Abbott has started enrolling first patients in the investigational device exemption (IDE) clinical trial of its new Esprit BTK Everolimus Eluting Resorbable Scaffold System, dubbed LIFE-BTK.
The LIFE-BTK trial is aimed at evaluating the safety and effectiveness the new drug-eluting resorbable scaffold (DRS) system to treat blocked arteries below the knees, or critical limb ischemia (CLI), in people with advanced peripheral artery disease (PAD).
Once the enrolment is complete, the LIFE-BTK trial is planned to evaluate the treatment using Esprit BTK resorbable scaffold, compared to Percutaneous Transluminal Angioplasty (PTA), in 225 patients with diseased vessels and blocked arteries.
Principal investigators of the clinical trial Ramon Varcoe said: “After a five-year feasibility study in assessing treatment of arteries below the knee with a different version of this technology, the outcomes suggest resorbable devices have significant potential to become the favored therapy for CLI patients.
“This technology offers the best of both worlds. The device provides a strong scaffold structure and delivers antiproliferative drugs, then disappears and is not an impediment for future interventions, surgery or imaging.”
Esprit BTK System features a scaffold, and a bioresorbable polymer
Balloon angioplasty is the current standard of care for patients suffering from CLI, which works by a small balloon delivered through a catheter to compress the blockage against the arterial wall, to open the blood vessel and restore the blood flow.
Treatment using only balloon angioplasty is said to result in poor short- and long-term results, and in most cases the vessels gets blocked after the treatment, needing additional treatment.
Abbott said that its Esprit BTK System is not a permanent implant like traditional metal stents.
The system supports the artery immediately after balloon angioplasty, and prevents the blood vessel from reclosing. The system has been granted the breakthrough device designation by the US Food and Drug Administration (FDA).
It comprises a thin strutted scaffold measuring 99 microns, made from poly-L-lactide (PLLA), a semi-crystalline bioresorbable polymer, designed to prevent vessel recoil and offer a platform for drug delivery.
The scaffold is uniformly coated with poly-D, L-lactide (PDLLA) and the cytostatic drug, everolimus. The implanted scaffold works by delivering the drug, which prevents the cell proliferation and reduces the growth of scar tissue in the affected area.
Abbott vascular business chief medical officer and medical affairs divisional vice president Nick West said: “Far too many people are impacted by peripheral artery disease, and this new drug-eluting resorbable scaffold is needed to offer meaningful improvements in how this disease is treated.
“Patients treated with balloon angioplasty often require repeat procedures on treated arteries, and therefore a drug-eluting resorbable device is ideally-suited to provide mechanical support for the vessel, reduce the chance of vessel re-narrowing and then gradually disappear over time.”