Abbott Initiates ABSORB III Trial in the United States

January 8, 2013—Abbott Vascular (Santa Clara, CA) announced the initiation of the ABSORB III clinical trial in the United States. This randomized, controlled trial is designed to enroll approximately 2,250 patients, the majority in the United States, in order to compare the performance of Abbott's drug-eluting Absorb bioresorbable vascular scaffold to the company's Xience family of drug-eluting stents in the treatment of coronary artery disease. Data from the ABSORB III trial will support regulatory filings for the Absorb device in the United States.

According to the company, the start of patient enrollment in this trial in the United States follows the recent international commercial launch of Absorb in Europe and parts of Latin America and Asia, including the recent regulatory approval and launch in India.

The primary endpoint of ABSORB III is target lesion failure at 1 year to measure the device's safety and efficacy. In addition, a subset of patients within the trial will be evaluated for novel endpoints such as vasomotion, a measure of how much natural motion returns to the vessel as Absorb dissolves into the arterial tissue.

In Abbott's press release, ABSORB III coprimary investigators Dean Kereiakes, MD, and Stephen Ellis, MD, commented on the device and the trial. Dr. Kereiakes serves as medical director of The Christ Hospital Heart & Vascular Center and the Lindner Research Center in Cincinnati and is professor of clinical medicine at Ohio State University. Dr. Ellis is section head of Interventional Cardiology at the Cleveland Clinic.

Dr. Kereiakes stated, “The deliverability of the Absorb device is impressive and similar to a best-in-class drug-eluting stent. Absorb combines the unique attributes of a dissolvable material with the established Multi-Link stent design, making the scaffold flexible and conformable to the vessel.”

Dr. Ellis added, “With the introduction of balloon angioplasty in the 1970s, cardiologists wanted to open a blocked vessel without leaving anything behind. Absorb represents the latest innovation that may help us reach this goal, which could result in important long-term benefits related to the restoration of natural vessel function. The data collected on Absorb from the ABSORB III trial could have the potential to drive significant changes in how cardiologists treat patients with coronary artery disease.”

Abbott advised that in the United States, Absorb is an investigational device, limited by law to investigational use. It is not approved or available for sale in the United States. Absorb is authorized for sale in CE Mark countries and is available in Europe, the Middle East, parts of Latin America, and parts of Asia Pacific, including India, Hong Kong, Malaysia, and New Zealand.