Abbott (NYSE: ABT) announced today that it has received CE Mark approval for the world's first drug eluting bioresorbable vascular scaffold (BVS) for the treatment of coronary artery disease. Abbott's BVS device restores blood flow by opening a clogged vessel and providing support to the vessel until the device dissolves within approximately two years, leaving patients with a treated vessel free of a permanent metallic implant. Abbott's BVS device will be commercialized under the brand name ABSORB™.
"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," said Patrick W. Serruys, M.D., Ph.D., professor of interventional cardiology at the Thoraxcentre, Erasmus University Hospital, Rotterdam, the Netherlands. "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."
ABSORB is made of polylactide, a proven biocompatible material that is commonly used in medical implants such as resorbable sutures. Since a permanent metallic implant is not left behind, a patient's vessel treated with ABSORB may ultimately have the ability to move, flex and pulsate similar to an untreated vessel. Restoration of these naturally occurring vessel functions, or vascular restoration therapy (VRT), is one of the features that makes ABSORB a significant innovation for patients in the treatment of coronary artery disease. In addition, continuing research indicates that the need to administer long-term dual anti-platelet therapy to patients may be reduced because the temporary scaffold is completely resorbed.
"Our ABSORB technology has the potential to revolutionize the treatment of coronary artery disease – with the prospect for positive therapeutic outcomes resulting from its unique ability to treat a blocked vessel, potentially restore natural vessel function and disappear within approximately two years after implant," said Robert B. Hance, senior vice president, vascular, Abbott. "Receiving CE Mark is a significant milestone on the path to providing patients with new treatment options for coronary artery disease. Abbott is committed to building the clinical and economic benefits of this therapy in anticipation of making it widely available in Europe by the end of 2012."
CE Mark approval for ABSORB in Europe was supported by data from the ABSORB clinical trials, which included patient follow-up out to three years. To further study the device in an expanded population, Abbott plans to initiate a randomized, controlled clinical trial in Europe later this year. The study will enroll approximately 500 patients at 40 centers throughout Europe and will compare ABSORB to Abbott's XIENCE PRIME, which, together with XIENCE V, is the market-leading drug eluting stent system in Europe. The trial will provide additional data to support European commercialization and reimbursement activities. A global trial, including the U.S. and other geographies, is planned for later this year.
In addition to clinical trial product, ABSORB will be made available in select sizes to a limited number of centers in Europe later this year and into 2012. This will enable physicians in these centers to increase their clinical experience with the technology and to continue to develop the therapy. A full-scale European commercial launch of ABSORB with a broad size matrix is planned by the end of 2012.
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