Abbott has secured the CE mark in Europe for its Esprit BTK Everolimus Eluting Resorbable Scaffold System (Esprit BTK System), a device intended to treat peripheral artery disease (PAD) below the knee.
This system is designed to maintain arterial openness and deliver the drug everolimus to aid vessel healing before dissolving over time.
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Traditionally, Europeans with PAD have been treated with balloon angioplasty, which involves using a catheter to insert a small balloon into the blocked artery to restore blood flow. However, Abbot states that this method often results in re-blockage, necessitating further interventions.
The Esprit BTK System is said to offer an alternative as the first resorbable scaffold specifically for below-the-knee use. This stent is implanted through a minimally invasive procedure and supports vessel healing until it can remain open independently, after which it dissolves.
Samih Al Mawass, divisional vice-president of Abbott’s Europe, Middle East and Africa (MENA) vascular business, said: “Abbott is an expert in the development of innovative treatments for vascular diseases, and 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 programme is focused on delivering meaningful innovation in the peripheral anatomy to help patients live healthier, fuller lives.”
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By GlobalDataIn November 2024, Abbott presented two-year clinical data from the LIFE-BTK trial at the Vascular InterVentional Advances (VIVA) Conference. The trial indicated that the Esprit BTK System led to improved patient outcomes compared to balloon angioplasty, with 48% fewer repeat procedures required over the study period.
The results showed a 28.7% improvement in primary patency and limb salvage, maintaining a comparable safety profile over two years.
The LIFE-BTK trial also demonstrated superior efficacy of the Esprit BTK System over balloon angioplasty at one year, with a 30.8% improvement in primary patency and limb salvage.
The system received approval from the US Food and Drug Administration in April 2024.
