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news.AngioScore, a developer of novel angioplasty catheters has announced that its flagship product, the AngioSculpt Scoring Balloon Catheter, has received import approval from Japan's Ministry of Health, Labor and Welfare for the interventional treatment of coronary artery disease in Japan.
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The AngioSculpt Scoring Balloon Catheter is said to represent the next generation in angioplasty catheters. Its innovative nitinol element provides unique anti-slipping properties while circumferentially dilating plaque, providing a precise and predictable dilatation across a wide range of lesion types.
Michael Van Zandt, CEO of USCI Japan, said: “This is our first MHLW/PMDA submission under Japan’s new Pharmaceutical Affairs Law. We see this as a milestone collaborative effort between government and industry, a concrete example of new speed and efficiencies in the Japanese health care approval system.”