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July 16, 2026
Abbott’s 76-mm Esprit-BTK System Receives FDA Approval
KEY TAKEAWAYS
- FDA approves a 76-mm version of Abbott’s Esprit BTK resorbable scaffold system for patients with CLTI.
- The longer scaffold is intended to reduce the number of devices needed to treat long BTK lesions and may improve procedural efficiency.
- The approval expands the Esprit BTK platform, which was first approved by the FDA in April 2024 based on results from the LIFE-BTK trial.
July 16, 2026—The FDA has approved Abbott’s longer length (76-mm) Esprit below-the-knee (BTK) system, a dissolving resorbable scaffold for the treatment of chronic limb-threatening ischemia (CLTI).
According to the company, the longer length Esprit is designed to improve procedural efficiency by allowing physicians to treat lesions using fewer devices, supporting a streamlined workflow. The device addresses a real-world clinical need, as most below-the-knee lesions in CLTI patients exceed 100 mm in length, while existing lengths can require multiple Esprit BTK scaffolds, increasing procedural time and complexity.
The longer length device builds on Abbott’s Esprit BTK scaffold design and over-the-wire platform. The device, which is supported by robust long-term clinical evidence, is designed for consistent coverage throughout the target lesion with marker systems to support accurate deployment.
In April 2024, Abbott announced FDA approval of the Esprit BTK transcatheter everolimus-eluting resorbable scaffold system for the treatment of patients with BTK CLTI. 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.
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