Abbott Initiates International ABSORB BTK Trial

September 8, 2011—Abbott Vascular (Santa Clara, CA) announced the initiation of ABSORB BTK, an international clinical trial evaluating the company's everolimus-eluting Absorb bioresorbable vascular scaffold (BVS) for the treatment of below-the-knee (BTK) critical limb ischemia. Dierk Scheinert, MD, is the Principal Investigator of the ABSORB BTK trial. Marc Bosiers, MD, enrolled the first patient in the trial.

According to Abbott Vascular, ABSORB BTK is a prospective, single-arm, multicenter trial designed to evaluate the safety and efficacy of the Absorb BVS in up to 90 patients with BTK critical limb ischemia at up to 10 clinical trial sites in Europe and New Zealand. The primary endpoint is a composite of freedom from major adverse limb events (major amputation or major reinterventions) within 1 year or death within 30 days of the procedure.

“Patients with critical limb ischemia often progress to where they have few options beyond limb amputation, so there is a tremendous need for new therapies to prevent this outcome," commented Dr. Scheinert. "The Absorb device represents the next generation in revascularization therapies that may hold promise for patients with vessel disease in the lower leg. With the ABSORB BTK trial, we will test whether this novel approach—restoring blood flow with a temporary scaffold—has the potential to improve the outcomes of patients with critical limb ischemia."

In January 2011, Abbott Vascular received CE Mark approval for the Absorb BVS for the treatment of coronary artery disease. In the United States, the device is under development and is not available for sale, the company advised.