The study findings will go towards Abbott’s Japanese regulatory application for the new device. The Absorb Bioresorbable Vascular Scaffold (BVS) is a drug-eluting stent designed to slowly dissolve into the heart vessel to help restore normal vessel function over time.
The Japanese study will observe about 400 CAD patients, split into 2 arms for treatment with either Absorb BVS or Abbott’s own Xience line of metallic stents; both devices deliver everolimus, an anti-proliferative drug. Researchers will monitor patients to look for long-term side effects of the Absorb treatment.
"While the clinical outcomes of Absorb have been demonstrated in international clinical trials, we now have the opportunity to understand the impact of this technology in Japanese patients in a comparative study, and hope the results of this effort support the process to make Absorb widely available for clinical use in Japan in the future," said principle trial investigator Dr. Takeshi Kimura in company remarks.
Abbott launched its Xience Xpedition coronary stent in the U.S. in January and just last month won European regulatory approval for its Xience Xpedition 48, which it calls the world’s longest coronary drug-eluting stent.