Abbott Laboratories (NYSE:ABT) announced today that they are initiating ESPRIT I which the company says is a first-of-its-kind clinical trial in Europe.
The trial is for performance evaluation of Esprit. The drug itself is a bioresorbable vascular scaffold (BVS) and is for “treatment of blockages in the superficial femoral arteries (SFA) and iliac arteries that have resulted in claudicatio,” according to Abbot, which also states that claudication is a common symptom in patients with peripheral artery disease (PAD) and “associated with diminished physical activity and poor quality of life for patients.”
“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.”
Abbot stated that the ESPRIT I trial is a single-arm, multi-center trial that has been designed safely to evaluate the performance of Esprit therapy in about 30 patients with claudication resulting from PAD of the superficial femoral arteries (SFA) or iliac arteries. The actual clinical test sites will be up to ten spread across Europe. Important to note, Abbot stated, “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.”
“ESPRIT I is the first clinical trial to evaluate our bioresorbable technology in patients with disease in the SFA and iliac arteries,” said Charles A. Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular. “In addition to ESPRIT I, we also are investigating our bioresorbable therapy for the treatment of below-the-knee critical limb ischemia – a severe form of PAD – in the ABSORB BTK trial. We’ve seen promising long-term clinical data with our bioresorbable therapy in coronary patients, and we believe there is potential for this technology in the treatment of PAD.”
Abbott Laboratories (NYSE:ABT) set a new 52-week high to end trading today at $55.65 per share on top of 9.1 million exchanged shares.