Abbott Initiates Clinical Trial to Study Drug Eluting Bioresorbable Therapy for Treatment of Peripheral Artery Disease
The Esprit drug eluting BVS is designed specifically for use in peripheral arteries and is made of polylactide, the same proven biocompatible material used in the company's Absorb™ drug eluting BVS for coronary artery disease. Absorb is authorized for sale in Europe and is investigational in the United States. Esprit is designed to restore blood flow by opening a blocked vessel and providing support until it is healed. Once the vessel can remain open without the extra support, the scaffold is designed to dissolve, leaving the vessel free of a permanent metallic implant. Because a permanent implant is not left behind, clinical outcomes may be improved and options for retreatment of the vessel preserved.
"Treating blockages in the SFA is a clinical challenge, as there are unique biomechanical forces exerted on the SFA during normal leg movement, which can lead to restenosis or re-narrowing of the vessel," said Johannes Lammer, M.D., professor of radiology at the Medical University of Vienna, Austria, and principal investigator for the ESPRIT I trial. "Current endovascular therapies, such as self-expanding stents and angioplasty balloons, have limitations and have not solved the problem of restenosis. A bioresorbable drug eluting device, designed to act as a temporary scaffold to support the vessel and then fully dissolve, may change the way we treat peripheral artery disease."
The ESPRIT I trial is a single-arm, multi-center trial designed to evaluate the safety and performance of the Esprit therapy in approximately 30 patients with claudication resulting from PAD of the SFA or iliac arteries. Up to 10 clinical trial sites in Europe will participate in the trial. Patients will undergo clinical hemodynamic (blood movement), functional and quality-of-life follow-up at one, six and 12 months and at two and three years following the procedure.
Most read news
Other news from the department research and development
Get the life science industry in your inbox
From now on, don't miss a thing: Our newsletter for biotechnology, pharma and life sciences brings you up to date every Tuesday and Thursday. The latest industry news, product highlights and innovations - compact and easy to understand in your inbox. Researched by us so you don't have to.