September 3, 2020
Abbott Begins LIFE-BTK Trial to Evaluate Esprit BTK Drug-Eluting Resorbable Scaffold to Treat CLI
September 3, 2020—Abbott announced the start of the LIFE-BTK clinical trial to evaluate the safety and effectiveness of the company’s new Esprit below-the-knee (BTK) everolimus-eluting resorbable scaffold system. The company advised that the Esprit BTK has been granted FDA Breakthrough Device designation, which streamlines review and premarket approval timelines.
According to Abbott, the United States investigational device exemption trial will evaluate the fully resorbable Esprit BTK device to treat critical limb ischemia (CLI) in patients with advanced peripheral artery disease (PAD). The first patient was enrolled by Danielle Bajakian, MD, at New York-Presbyterian/Columbia University Irving Medical Center in New York, New York.
The LIFE-BTK trial is a prospective, randomized controlled clinical trial comparing Esprit BTK to percutaneous transluminal angioplasty. The study objective is to evaluate the safety and efficacy in CLI patients with up to two lesions in separate infrapopliteal vessels.
The LIFE-BTK trial is designed to evaluate the Esprit BTK resorbable scaffold in 225 patients at centers around the world. To date, the trial has sites in Australia, Japan, New Zealand, Singapore, and the United States. The Principal Investigators are Brian DeRubertis, MD; Sahil Parikh, MD; and Ramon Varcoe, MBBS.
“After a 5-year feasibility study in assessing treatment of arteries BTK with a different version of this technology, the outcomes suggest resorbable devices have significant potential to become the favored therapy for CLI patients,” commented Dr. Varcoe in Abbott’s announcement. “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.”