Abbott Announces Start of Trial to Evaluate the New Esprit™ BTK Drug-Eluting Resorbable Scaffold

Abbott has 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. 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). The first patient was enrolled by Danielle Bajakian, M.D., a vascular surgeon at New York-Presbyterian/Columbia University Irving Medical Center.

"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, M.D., 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.

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.

Abbott's Esprit BTK System is not a permanent implant; it provides support to an artery immediately after a balloon angioplasty, preventing the vessel from reclosing. Once implanted, the scaffold delivers a drug over a few months that promotes healing and keeps the artery open. The scaffold is naturally resorbed into the body over time, like dissolving sutures, and ultimately leaves only a healed artery behind. Long-term clinical data from a meta-analysis of randomized Absorb trials suggested that bioresorbable scaffolds might be an acceptable alternative to metallic DES for many patients with coronary artery disease.

The LIFE-BTK trial is the first Investigational Device Exemption trial in the U.S. to evaluate a fully dissolvable device to treat critical limb ischemia in people battling advanced stages of peripheral artery disease (PAD). To date, the trial has sites in Australia, Japan, New Zealand, Singapore and the United States.

The trial will be led by principal investigators Brian DeRubertis, M.D. (vascular surgeon, UCLA), Sahil Parikh M.D., (interventional cardiologist, New York-Presbyterian/Columbia University Irving Medical Center, who serves on the medical advisory board for Abbott's vascular division), and Ramon Varcoe MBBS MS FRACS Ph.D., (University New South Wales, Sydney, Australia).

The Esprit BTK System consists of a thin strutted scaffold which measures 99 microns made from poly-L-lactide (PLLA), a semi-crystalline bioresorbable polymer engineered to resist vessel recoil and provide a platform for drug delivery. The scaffold is uniformly coated with poly-D, L-lactide (PDLLA) and the cytostatic drug, everolimus. PDLLA is an amorphous bioresorbable polymer coating designed to allow controlled drug release. The controlled release of everolimus, a drug that acts to retard cell proliferation, reduces scar tissue growth in the affected area, which can cause vessel blockage. The Esprit BTK System is an investigational device only in the U.S.