US-based medical device company Abbott has secured CE mark approval for its Esprit BTK Everolimus Eluting Resorbable Scaffold System in Europe.
The Esprit BTK system is a dissolving stent designed to treat peripheral artery disease (PAD) below the knee.
PAD is a circulation disorder characterised by blockage in arteries due to the buildup of plaque, preventing blood and oxygen flow to the lower extremities.
It causes severe pain, non-healing wounds, and potentially limb amputations.
The scaffold system helps keep arteries open while delivering everolimus to aid vessel healing, dissolving once the artery can remain open on its own.
Abbott Europe, Middle East & Africa (EMEA) vascular business divisional vice president Samih Al Mawass said: “Abbott is an expert in the development of innovative treatments for vascular diseases and has pioneered dissolving stents for people with PAD below the knee.
“With the Esprit BTK System, we’re helping to restore blood flow without leaving a permanent implant behind.
“Our resorbable program is focused on delivering meaningful innovation in the peripheral anatomy to help patients live healthier, fuller lives.”
Balloon angioplasty is a common treatment for PAD, which often results in re-blockage, necessitating further interventions.
Abbott said that its Esprit BTK system is implanted through a minimally invasive procedure to clear the blockage.
After clearing, the scaffold supports vessel healing before dissolving over time.
In November last year, two-year data from the LIFE-BTK trial showed that the Esprit BTK system improved patient outcomes compared to balloon angioplasty.
Also, the scaffold system showed 48% fewer repeat procedures.
Abbott received the US Food and Drug Administration (FDA) approval for its Esprit BTK resorbable scaffold system in April last year.
University Hospital Leipzig department of angiology head Dierk Scheinert said: “For too long, patients with severe PAD below the knee have had limited treatment options and were often faced with potential amputations.
“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.”
