FDA approves novel bioresorbable scaffold for treating chronic limb-threatening ischemia
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Key takeaways:
- The FDA approved a novel bioresorbable scaffold for the treatment of chronic limb-threatening ischemia.
- The approval was based on the results of the LIFE-BTK trial presented at TCT 2023.
Abbott announced the FDA has approved its novel below-the-knee, bioresorbable, drug-eluting scaffold for people with chronic limb-threatening ischemia.
The approval is based on the results of the LIFE-BTK trial, presented at Transcatheter Cardiovascular Therapeutics 2023, which compared the scaffold (Esprit BTK everolimus-eluting resorbable scaffold system) with conventional balloon angioplasty for 261 patients with CLTI.
As Healio previously reported, the scaffold was superior to angioplasty, with lower rates of amputation, occlusion of the target vessel, clinically driven revascularization of the target lesion and binary restenosis of the target lesion at 1 year.
The dissolvable, everolimus-eluting scaffold is made of a material similar to dissolving sutures and implanted via minimally invasive, catheter-based procedure, according to a press release from Abbott.
Once the blockage is open, the scaffold provides support for approximately 3 years, according to the release.
“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, MD, an interventional cardiologist at Columbia University Irving Medical Center and one of the principal investigators of the LIFE-BTK trial, said in the release. “By introducing a treatment option that is superior to balloon angioplasty, Abbott is changing the landscape of CLTI therapy.”
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