ESPRIT I in Europe Evaluates Abbott's Drug-Eluting BVS for PAD

December 22, 2011—Abbott Vascular (Santa Clara, CA) announced the initiation of the ESPRIT I clinical trial in Europe.

The company stated that ESPRIT I is a single-arm, multicenter trial designed to evaluate the safety and performance of the Esprit bioresorbable vascular scaffold (BVS) in approximately 30 patients with claudication from peripheral artery disease (PAD) of the superficial femoral (SFA) or iliac arteries. Up to 10 clinical trial sites in Europe will participate in the trial. Patients will undergo clinical hemodynamic, functional, and quality-of-life follow-up at 1, 6, and 12 months and at 2 and 3 years after the procedure. Prof. Johannes Lammer, MD, is Principal Investigator for the ESPRIT I trial. Marc Bosiers, MD, enrolled the trial's first patient.

According to Abbott Vascular, the Esprit everolimus-eluting BVS is designed specifically for use in peripheral arteries. The device is made of polylactide, the same biocompatible polymer used in the company's Absorb drug-eluting BVS for treating coronary artery disease. Esprit has a different scaffold design and comes in larger diameters and longer lengths. The Absorb coronary drug-eluting BVS is authorized for sale in Europe and is an investigational device in the United States. The Esprit peripheral drug-eluting BVS is currently investigational and is not available for sale, the company advised.

“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 renarrowing of the vessel,” commented Prof. Lammer, MD. “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 PAD.”