Abbott announced that it has received CE Mark approval for its Esprit BTK everolimus-eluting resorbable scaffold system, designed to treat patients with peripheral artery disease (PAD) below the knee (BTK).
The Esprit BTK scaffold is engineered to hold arteries open while delivering the drug everolimus to aid vessel healing. Over time, the scaffold naturally dissolves, leaving behind no permanent implant. Constructed from a material similar to dissolving sutures, the device is implanted using a minimally invasive catheter-based procedure through a small incision in the leg.
After clearing the blockage, the scaffold provides temporary vessel support until the artery can remain open independently, after which it gradually resorbs.
Esprit BTK received FDA approval in April 2024, following positive results from the LIFE-BTK clinical trial, which demonstrated superior outcomes compared to balloon angioplasty. With the new CE mark, Abbott can now begin commercial rollout of the device in Europe.
“Abbott has long been a leader in advancing vascular innovation,” said Samih Al Mawass, Divisional VP for EMEA, Abbott Vascular. “The Esprit BTK system restores blood flow without leaving a permanent implant, helping patients with PAD live healthier, fuller lives.”