Abbott today announced it has received CE mark approval in Europe for the Esprit BTK everolimus-eluting resorbable scaffold system (Esprit BTK system), a technology designed for the treatment of below-the-knee (BTK) peripheral arterial disease (PAD).
Abbott notes that the Esprit BTK system is the first resorbable scaffold of its kind for use below the knee. At VIVA 2024, Abbott released late-breaking clinical data on the LIFE-BTK trial two-year results. The trial demonstrated that, compared to balloon angioplasty, the Esprit BTK system results in improved patient outcomes and 48% fewer repeat procedures over the study period.
“For too long, patients with severe PAD below the knee have had limited treatment options and were often faced with potential amputations,” said Dierk Scheinert (University Hospital Leipzig, Leipzig, Germany). “With CE mark, the Esprit BTK system offers a resorbable scaffold backed by strong data and proven superiority over balloon angioplasty—giving physicians a novel, innovative tool to treat the most severe forms of PAD more effectively and improve patient outcomes across Europe.”
“Abbott is an expert in the development of innovative treatments for vascular diseases, and pioneered dissolving stents for people with PAD below the knee,” said Samih Al Mawass, divisional vice president of Europe, Middle East & Africa (EMEA) at Abbott’s vascular business. “With the Esprit BTK system, we’re helping to restore blood flow without leaving a permanent implant behind. Our resorbable programme is focused on delivering meaningful innovation in the peripheral anatomy to help patients live healthier, fuller lives.”
The Esprit BTK system received US Food and Drug Administration (FDA) approval in April 2024.
