Abbott Secures CE Mark for Longer-Length Esprit BTK System for Severe PAD in Europe
Abbott has secured CE Mark for its new longer-length Esprit BTK System (76 mm) for the treatment of chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease (PAD) that affects millions of people across Europe. The approval follows U.S. FDA clearance of the longer-length system earlier this year.
CLTI can cause extreme pain, open wounds that don't heal and, in some cases, amputation. Within five years of diagnosis, CLTI carries a 50% mortality rate, worse than breast, colorectal and prostate cancer combined.
The longer-length Esprit addresses a real-world clinical need: most below-the-knee lesions in CLTI patients exceed 100 mm, while existing lengths can require multiple scaffolds, increasing procedural time and complexity. The 76 mm length allows physicians to treat longer lesions with fewer devices. It builds on Abbott's proven Esprit BTK platform and over-the-wire (OTW) design, the only dissolving resorbable scaffold (DRS) on the market with robust long-term clinical evidence.
""Abbott has long been at the forefront of dissolving scaffold innovation, and we continue to build on that legacy to address unmet needs in vascular care," said Samih Al Mawass, Divisional Vice President, EMEA, Abbott Vascular. "The longer-length Esprit scaffold was developed with the realities of clinical practice in mind, where below-the-knee lesions in patients with critical limb-threatening ischemia are often extensive and difficult to treat. This CE Mark represents an important advancement for physicians across Europe, providing a dedicated solution for complex cases while expanding treatment options for patients at risk of limb loss."
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