FDA Approves Abbott's Novel Dissolvable Stent Therapy for Peripheral Artery Disease

The US Food and Drug Administration (FDA) has approved a new device to treat blocked arteries below the knee (BTK) in patients with peripheral artery disease (PAD).¹

Abbott’s Esprit BTK Everolimus Eluting Resorbable Scaffold System (Esprit BTK System) was approved by the agency to treat chronic limb-threatening ischemia below the knee. The dissolvable stent is a first-of-its-kind device comprised of material consistent with dissolving suture, providing patients with opened arteries while vessel-treating Everolimus is delivered.

“Until today, there were no stents or drug-coated balloons approved for use below the knee in the US,” Abbott stated in a press release accompanying the approval. “The standard of care has been 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.”

The clinical evidence supporting the Esprit BTK System came from the pivotal LIFE-BTK trial, presented in a late-breaking session at the Transcatheter Cardiovascular Therapeutics (TCT) Conference in San Francisco, October 2023. The data, published in New England Journal of Medicine,² showed that 135 patients treated with the dissolvable scaffold therapy avoided amputation above the ankle of the target limb; target vessel occlusion; clinically-driven revascularization of the target lesion; and binary restenosis of the target lesion, all at 1 year-post treatment.

Only 48 of the patients treated in the comparator angioplasty arm achieved the primary outcome (74% vs 44%; absolute difference, 30 [95% CI, 15 – 45; P <.001]). Investigators in the LIFE-BTK trial additionally observed non-inferior safety with the dissolvable stent treatment to angioplasty, with approximately 97% treated patients in the former arm achieving freedom from major adverse limb events at 6 months or perioperative death, versus 100% of patients in the latter arm.

“Drug-eluting devices that inhibit neointimal hyperplasia have not been used routinely for the treatment of infrapopliteal artery disease. In numerous trials of drug-coated balloons and drug-eluting scaffolds and stents, the treatment has not resulted in greater patency than angioplasty or has had practical limitations,” investigators wrote. “Of all the available approaches, the use of coronary drug-eluting stents with sirolimus analogues in below-the-knee interventions has shown the most promise for maintaining primary patency.”

It is estimated that more than 20 million Americans are affected by PAD, though only 1 in 10 have been diagnosed. Chronic limb-threatening ischemia can result in extreme pain, unhealing open wounds, and a significantly increased risk of amputation. Abbott noted the event is associated with a lower survival rate than breast, colorectal and prostate cancer combined.¹

"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," Sahil A. Parikh, M., Columbia University Irving Medical Center, and LIFE-BTK trial principal investigator, said in a statement. "By introducing a treatment option that is superior to balloon angioplasty, Abbott is changing the landscape of (chronic limb-threatening ischemia) therapy."

References

1. ^{Abbott. ABBOTT'S BREAKTHROUGH DISSOLVING STENT RECEIVES FDA APPROVAL FOR ARTERIES BELOW THE KNEE. Press release. Published April 29, 2024. https://abbott.mediaroom.com/2024-04-29-Abbotts-Breakthrough-Dissolving-Stent-Receives-FDA-Approval-for-Arteries-Below-the-Knee}
2. ^{Varcoe RL, DeRubertis BG, Kolluri R, et al. Drug-Eluting Resorbable Scaffold versus Angioplasty for Infrapopliteal Artery Disease. N Engl J Med. 2024;390(1):9-19. doi:10.1056/NEJMoa2305637}