Abbott’s Esprit BTK Everolimus-Eluting Resorbable Scaffold Gains FDA Approval

April 29, 2024—Abbott announced that the FDA has approved the transcatheter Esprit BTK everolimus-eluting resorbable scaffold system for the treatment of patients with below-the-knee (BTK) chronic limb-threatening ischemia (CLTI).

According to the company, the Esprit BTK system is designed to completely dissolve after keeping arteries open and deliver everolimus to support vessel healing. The Esprit BTK scaffold provides support for approximately 3 years until the vessel is strong enough to remain open on its own.

Abbott stated that the results of the LIFE-BTK trial demonstrated that the Esprit BTK system reduces disease progression and helps improve medical outcomes compared to balloon angioplasty, the current standard of care.

The LIFE-BTK trial’s primary efficacy endpoint of primary patency plus limb salvage was met and showed that Esprit BTK is superior to balloon angioplasty in lowering the risk of total obstruction of the target vessel, narrowing of the target lesion, major amputation, and repeat interventions of the target lesion. The data were presented as a late-breaking clinical trial at TCT 2023, the 35th annual Transcatheter Cardiovascular Therapeutics scientific symposium held October 23-26 in San Francisco, California. The study was simultaneously published by Ramon L. Varcoe, MBBS, et al in The New England Journal of Medicine (2024;390:9-19).

Sahil A. Parikh, MD, with Columbia University Irving Medical Center in New York, New York, is one of the Principal Investigators of LIFE-BTK.

“The FDA approval of Abbott’s Esprit BTK system marks a significant milestone in our fight against peripheral artery disease below the knee and should usher in a new era of improved outcomes for people worldwide,” commented Dr. Parikh in the company’s press release. “By introducing a treatment option that is superior to balloon angioplasty, Abbott is changing the landscape of CLTI therapy.”