Integrity stent
Medtronic Inc. (NYSE:MDT) plans to launch two next-generation stent systems in Japan as the devices won regulatory approval and reimbursement from the country’s Ministry of Health, Labor & Welfare.
The Integrity coronary stent’s reimbursement took effect on Sept. 1 and the Endurant AAA stent graft’s reimbursement is set to take effect Nov. 1.
Both devices won Japanese regulatory approval over the summer, according to a press release.
The Integrity stent introduces continuous sinusoid technology, through which the stent is constructed using a single strand of wire shaped into a wave-like pattern. The new design gives the Integrity stent flexibility and conformability as well as a continuous range of motion, according to the Minneapolis, Minn.-based medical device giant.
The Endurant AAA stent graft, used in treatment of abdominal aortic aneurysms, reinforces weak spots in blood vessels without the need for open-heart surgery.
The Endurant, which is delivered via catheter through the femoral artery, won premarket approval clearance from the FDA in December 2010 and CE Mark approval in the European Union in 2008.
Both devices are the global market leaders for their categories, according to the press release.
