Abbott Laboratories’ new Absorb bioresorbable heart stent has been approved in Japan to treat coronary artery disease, joining the U.S. and Canada in countries that have approved its use, according to a statement from Abbott.
The stent, which fully dissolves over approximately three years, restores vasomotor function and pulsatility, and allows the heart to function more naturally than it would with a metallic stent.
New clinical trial data was recently presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2016 conference last week, and it showed that that the stent wasn’t outperforming metallic ones.
"We're very excited to bring the promise of Absorb to patients in Japan," said Deepak Nath, PhD, senior vice president at Abbott Vascular, in a statement. "We believe the Absorb bioresorbable stent can help people live better, healthier lives without the concern of a having a metal implant."
About 1.73 million in Japan have heart disease, and 71,700 people die each year from coronary artery disease.
"Absorb has the potential to address the unsolved challenges of managing coronary artery disease with conventional drug eluting metallic stents," said Takeshi Kimura, MD, PhD, director of cardiovascular medicine at Kyoto University Hospital in Japan and the principal investigator of Absorb Japan, the clinical study that led to the MHLW's approval of the device, in a statement. "Our research, which involved 400 patients at 38 Japanese sites, shows that this fully dissolving stent delivered comparable results to the best-in-class Abbott Xience metallic drug-eluting stent on clinically important measures of safety and efficacy."