Abbott announced the start of the LIFE-BTK clinical trial to evaluate the safety and effectiveness of the company's new Esprit BTK Everolimus Eluting Resorbable Scaffold System, according to a press release. This is the first Investigational Device Exemption (IDE) trial in the U.S. to evaluate a fully resorbable device to treat blocked arteries below the knees, or critical limb ischemia (CLI), in people battling advanced stages of peripheral artery disease (PAD).
"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," said Nick West, MD, divisional vice president, Medical Affairs, and chief medical officer in Abbott's vascular business. "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."
For people with CLI, blocked vessels impair blood flow to the lower extremities, which can lead to severe pain, wounds, and in some cases, limb amputation. Globally, more than 200 million people suffer from PAD, disproportionally affecting people in underserved communities. Worse, up to 40 percent of patients with CLI currently undergo amputations, many of which could be prevented by eliminating healthcare disparities.
Currently, the standard of care for patients battling CLI is balloon angioplasty, which relies on a small balloon delivered via a catheter to the blockage to compress it against the arterial wall, opening the vessel and restoring blood flow. However, blockages treated only with balloon angioplasty have poor short- and long-term results, and in many instances the vessels become blocked again, requiring additional treatment.
There are no drug-eluting stents (DES), drug-coated balloons (DCB) or bare-metal stents (BMS) approved for use below the knee (BTK) in the U.S. With the limited options for BTK, new treatment options are needed. The U.S. Food and Drug Administration (FDA) has granted Esprit BTK breakthrough device designation, which streamlines review and pre-market approval timelines. Once fully enrolled, the LIFE-BTK trial will evaluate the Esprit BTK resorbable scaffold in 225 patients at centers around the world. The study is the first of its kind and an evolution of prior studies examining resorbable technology in treating diseased vessels and blocked arteries.
