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Abbott announced Monday that the Japanese Ministry of Health, Labour and Welfare approved the company's Absorb GT1 bioresorbable vascular scaffold system, making it the first fully dissolving heart stent available to treat coronary artery disease in the country. Deepak Nath, Abbott's senior vice president of vascular, remarked that "we believe the Absorb bioresorbable stent can help people live better, healthier lives without the concern of a having a metal implant."
According to Abbott, the approval was based on results from the ABSORB Japan trial, in which the Absorb stent demonstrated non-inferior safety and efficacy at one year compared with the company's permanent drug-eluting stent Xience in patients with coronary heart disease.
Takeshi Kimura, principal investigator of the trial, said that "Absorb has the potential to address the unsolved challenges of managing coronary artery disease with conventional drug eluting metallic stents." Kimura added that "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."
Abbott noted that the Absorb stent is made of a naturally dissolving material that disappears completely in around three years, "once it has done its job of keeping a clogged artery open and promoting healing of the treated artery segment." Absorb was recently approved in the US and Canada.
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