January 10, 2011 – European CE mark approval was announced today for the Abbott, Absorb drug-eluting bioresorbable coronary stent. It is the first bioresorbable stent to gain regulatory approval anywhere in the world. Full commercial launch in Europe is planned by the end of 2012.
The Absorb is the 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. The stent elutes the antiproliferative drug everolimus to inhibit treatment site neointimal tissue growth.
"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."
The Absorb stent 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 antiplatelet 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 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 about 500 patients at 40 centers throughout Europe and will compare Absorb to Abbott's Xience Prime stent, 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 United States and other countries, 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.
ABSORB Clinical Trials
The ABSORB trial is the world's first clinical trial evaluating a drug-eluting BVS for coronary artery disease, and Abbott is the only company with long-term, four-year clinical data on a complete patient set evaluating the safety and performance of a drug-eluting BVS. The ABSORB trial is a prospective, nonrandomized (open label), two-phase study that enrolled 131 patients from Australia, Belgium, Denmark, France, the Netherlands, New Zealand, Poland and Switzerland. Key endpoints of the study include assessments of safety – major adverse cardiac events (MACE) and treated-site thrombosis rates – at 30 days and at six, nine, 12 and 24 months, with additional annual clinical follow-up for up to five years, as well as an assessment of the acute performance of the BVS device, including successful deployment of the system. Other key endpoints of the study include imaging assessments by angiography, intravascular ultrasound (IVUS), optical coherence tomography (OCT), and other state-of-the-art invasive and non-invasive imaging modalities at six, 12 and 18 months and at two, three and five years.
Results from the first stage of the ABSORB trial with 30 patients demonstrated the BVS successfully treated coronary artery disease and was resorbed into the walls of treated arteries within about two years. Patients in this first stage of the ABSORB trial experienced no thrombosis out to four years and no new MACE between six months and four years (3.4 percent at four years).
Nine-month results from the 101 patients enrolled in the second stage of the ABSORB trial showed that the MACE rate remained consistent at 5 percent at nine months. There were no reports of blood clots in any of the 101 patients at nine months.
The ABSORB EXTEND trial is a single-arm study that will evaluate patients at up to 100 centers in Europe, Asia Pacific, Canada and Latin America. The trial will enroll about 1,000 patients with more complex coronary artery disease.
For more information: www.abbottvascular.com