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.”