The first patient in Japan has been treated with Abbotts’ Absorb bioresorbable vascular scaffold (BVS) as part of the ABSORB EXTEND global clinical trial. To date, more than 300 patients in Europe, Latin America and Asia Pacific have been enrolled in this trial.
Absorb 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 first patient in Japan was treated in the ABSORB EXTEND clinical trial by Shigeru Saito, director, Cardiology and Catheterization Laboratories, and vice president, Shonan Kamakura Hospital, Kanagawa, Japan.
“Abbott’s BVS technology has the potential to open up a new therapy option for physicians treating patients with coronary artery disease in Japan,” said Saito. “For Japanese patients, this technology will hold tremendous appeal, as it is designed to treat a clogged blood vessel like a drug eluting stent and then dissolve, thereby restoring a more natural vessel function without leaving a permanent metallic implant behind in the body. Our hope is that our participation in the ABSORB EXTEND trial will be a meaningful contribution toward making this innovative technology available to patients in Japan.”
Absorb is made of polylactide, a proven biocompatible material that is commonly used in medical implants such as dissolving sutures. Because a permanent metallic implant is not left behind, a vessel treated with this device may ultimately have the ability to move, flex, pulsate and dilate. Restoration of these naturally occurring vessel functions is one of the features that makes this device a significant innovation for patients in the evaluation and treatment of coronary artery disease. In addition, continuing research will show whether the need to administer long-term dual anti-platelet therapy to patients is necessary once the temporary scaffold is metabolised.
The Absorb BVS received CE mark approval for the treatment of coronary artery disease and is under clinical investigation in several countries around the world.
About the ABSORB EXTEND clinical trial
The ABSORB EXTEND trial is a large-scale, single-arm trial that will enrol approximately 1,000 patients with complex coronary artery disease at up to 100 centres in Europe, Asia Pacific, Canada and Latin America.
Data from this trial may be used to support approval in various markets around the world. 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, 12, 24 and 36 months, as well as an assessment of the acute performance of the bioresorbable vascular scaffold, including successful deployment of the system. Other key endpoints in a sub-group study include imaging assessments by angiography, intravascular ultrasound (IVUS), optical coherence tomography (OCT), and other imaging modalities.