Abbott Vascular's Absorb Vascular Scaffold Approved in Europe

January 10, 2011—Abbott Vascular (Santa Clara, CA) announced that it has received CE Mark approval for the drug-eluting Absorb bioresorbable vascular scaffold for treating coronary artery disease. The device restores blood flow by opening a clogged vessel and providing support to the vessel until the device dissolves within approximately 2 years, leaving patients with a treated vessel that is free of a permanent metallic implant.

"The CE Mark approval for Absorb in Europe is a significant accomplishment that validates the impressive clinical results that have been observed with this device," commented Patrick W. Serruys, MD. “Abbott's Absorb has the potential to change the way patients with coronary artery disease are treated, as it does what no other drug-eluting coronary device has been able to do before—completely dissolve and potentially restore natural vessel function in a way not possible with permanent metallic implants."



According to Abbott Vascular, CE Mark approval for Absorb was supported by data from the ABSORB clinical trials, which included patient follow-up out to 3 years. Abbott Vascular plans to further study the device in an expanded population with a randomized, controlled clinical trial in Europe to be initiated later this year. The study will enroll approximately 500 patients at 40 centers throughout Europe and will compare Absorb to Abbott Vascular's Xience Prime drug-eluting stent system. The trial will provide additional data to support European commercialization and reimbursement activities. A global trial, including the United States and other markets, is planned for later this year.

Absorb will be made commercially available in select sizes to a limited number of centers in Europe later this year and into 2012. The company is planning a full-scale European launch of Absorb, with a broad size matrix by the end of 2012. The company advised that Absorb is currently under development and is not available for sale in the United States.