Abbott (NYSE:ABT) announced today that it started the LIFE-BTK clinical trial for its Espirit BTK everolimus-eluting resorbable scaffold system.
According to a news release, Abbott’s Espirit system is the first to begin an investigational device exemption (IDE) trial in the U.S. for a fully resorbable device for treating below-the-knee blocked arteries or critical limb ischemia (CLI) in people battling advanced stages of peripheral artery disease (PAD).
Patients battling CLI currently undergo balloon angioplasty, the standard of care which Abbot said has shown poor short-term and long-term results and often the vessels become blocked again and require additional treatment. Presently, no drug-eluting stents, drug-coated balloons or bare-metal stents are approved for BTK use in the U.S.
Abbott’s Espirit BTK system is not a permanent implant, unlike traditional metal stents, and it offers support to an artery immediately after balloon angioplasty to prevent the vessel from closing again. Once implanted, Espirit delivers a drug over a few months in an effort to heal the artery and keep it open before the scaffold is naturally resorbed into the body.
Espirit BTK is made from poly-L-lactide, a semi-crystalline bioresorbable polymer engineered to resist vessel recoil and provide a platform for drug delivery, according to Abbott. It performs a controlled release of everolimus, which acts to retard cell proliferation and reduce scar tissue growth in the affected area.
The LIFE-BTK trial is slated to evaluate the scaffold in 225 patients at multiple centers around the world, which, to date, are located in the U.S., Australia, Japan, New Zealand and Singapore. The prospective, randomized controlled trial will compare Espirit BTK to percutaneous transluminal angioplasty (PTA), observing the safety and efficacy of the treatments in CLI patients with up to two lesions in separate infrapopliteal vessels.
“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,” Abbott divisional VP of medical affairs & chief medical officer for its vascular business Dr. Nick West said in the release. “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.”
