Journal of Invasive Cardiology

ABBOTT PARK, Ill., Dec. 8, 2011 – Abbott today announced the initiation of ABSORB II, the first randomized, controlled, multi-center clinical trial to evaluate the safety, efficacy and performance of the Absorb™ bioresorbable vascular scaffold (BVS) compared to the company's Xience Prime™ Everolimus-Eluting Coronary Stent System. Approximately 500 patients with coronary artery disease will be enrolled at about 40 investigational sites in Europe and New Zealand. The first patient was enrolled by Philip MacCarthy, MD, consultant cardiologist and clinical lead, and Jonathan Hill, MD, consultant cardiologist, at King's College Hospital in London.

Absorb is a bioresorbable scaffold designed to treat a patient's blocked vessel and then fully dissolve, leaving the vessel free of a permanent metallic implant. Because a permanent implant is not left behind, naturally occurring vessel functions may be restored. Absorb has CE Mark and is authorized for sale in Europe for the treatment of coronary artery disease. In the United States, Absorb currently is investigational and is not available for sale.

"Absorb has the potential to be an important advancement in the field of interventional cardiology, as clinical trials of this dissolvable device to date suggest that a permanent implant may not be needed to restore and maintain blood flow to the heart," said Patrick W. Serruys, MD, PhD, professor of interventional cardiology at the Thoraxcentre, Erasmus University Hospital, Rotterdam, the Netherlands and primary investigator for the ABSORB II clinical trial. "The ABSORB II trial is designed to test unique endpoints to determine the differences between Absorb and a permanent metallic implant, which may provide us with valuable insight into the potential uses of bioresorbable technology in patients with coronary artery disease."

The ABSORB II clinical trial will enroll approximately 500 patients at about 40 investigational sites in Europe and New Zealand. Patients will be randomized at a ratio of 2-to-1 (Absorb to Xience Prime). The primary endpoints of the trial are change in dimension of the lumen over time and vasomotion (vessel movement) at the treated vessel segment, which will be assessed based on changes in the vessel diameter in response to a stimulus. Clinical endpoints, including death, myocardial infarction, target lesion revascularization, and scaffold/stent thrombosis, will be assessed at 30 and 180 days and at one, two and three years post-treatment. Quality-of-life measures will be assessed prior to treatment, at 180 days and at one, two and three years post-treatment.

About the Absorb Bioresorbable Vascular Scaffold

Absorb is made of polylactide, a proven biocompatible material that is commonly used in medical implants such as dissolvable sutures. Studies to date have shown that the Absorb device restores blood flow by opening a blocked vessel and providing support to the vessel until the device dissolves after approximately two years. In January 2011, Abbott announced that Absorb received CE Mark and is authorized for sale in Europe for the treatment of coronary artery disease. In the U.S., Absorb currently is investigational and is not available for sale.

Abbott has completed one clinical trial called ABSORB and currently is conducting a second trial called ABSORB EXTEND to evaluate the company's bioresorbable device for the treatment of coronary artery disease. The ABSORB clinical trial, which is the first to evaluate a drug-eluting BVS for the treatment of coronary artery disease, is a prospective, non-randomized (open label), two-stage study that was conducted in Europe and New Zealand.

In the first stage of the trial, 30 patients were enrolled. The five-year results showed no reports of cardiac death, blood clots or ischemia-driven target lesion revascularization. The major adverse cardiac event (MACE) rate at five years was 3.4 percent, with no new events reported between six months and five years. In the second stage of the trial, 101 patients were enrolled. Eighteen-month data from all 101 patients showed no reports of cardiac death or blood clots. Two-year results in 44 patients showed no reports of blood clots and a MACE rate of 6.8 percent. Imaging data at two years showed a late loss of 0.27 mm, which is comparable to the one-year result. Of the patients' vessels that were assessed for vasomotor function at two years, the majority showed signs of vasomotion, suggesting that vessel movement was observed in the arteries of these patients as their vessels were no longer constrained by the scaffold.

The ABSORB EXTEND trial is a large-scale, single-arm study that will evaluate Absorb in patients at up to 100 centers in Europe, Asia Pacific, Canada and Latin America. The trial will enroll approximately 1,000 patients with complex coronary artery disease.

Abbott’s BVS delivers everolimus, an anti-proliferative drug. Everolimus is developed by Novartis Pharma AG and is licensed to Abbott by Novartis for use on its drug eluting vascular devices. Everolimus has been shown to inhibit treated-site neointimal growth in the coronary vessels following vascular device implantations, due to its anti-proliferative properties.

Abbott's news releases and other information are available on the company's website at www.abbott.com.