Abbott Begins Randomized Clinical Trial in Japan to Evaluate the Absorb™ Bioresorbable Vascular Scaffold

Abbott

today announced that it has initiated the ABSORB Japan randomized controlled clinical trial to evaluate the Absorb™ Bioresorbable Vascular Scaffold (BVS) in patients with coronary artery disease (CAD), the most common form of heart disease.^1 The results of this trial will support regulatory filings with the Japanese Pharmaceutical and Medical Devices Agency (PMDA) for approval of Absorb BVS in Japan. The Absorb BVS, a drug eluting, fully bioresorbable vascular scaffold, is a small mesh tube designed to open a blocked heart vessel, restore blood flow to the heart and then dissolve into the vessel over time.^2 Unlike a metallic stent that remains permanently in the body, Absorb is referred to as a scaffold to indicate that it is a temporary structure. Abbott's Absorb is made of polylactide, a naturally dissolvable material that is commonly used in medical implants such as dissolving sutures. CAD is the leading cause of death in the world.^3 In Japan, changes in diet and lifestyle have raised concerns of a potential increase in heart disease-related deaths.^4 According to the World Health Organization (WHO), cardiovascular disease is responsible for nearly one-third of all deaths in Japan.^5 ABSORB Japan will enroll approximately 400 patients and compare the performance of Absorb to Abbott's market-leading XIENCE™ family of metallic drug eluting stents. The primary endpoint is target lesion failure (TLF) at one year, a combined measure of safety and efficacy of the device. Takeshi Kimura, M.D., professor, Department of Cardiovascular Medicine, Kyoto University Hospital, is the principal investigator of the ABSORB Japan trial.