AngioScore, Inc. announced that Japan’s Ministry of Health, Labor and Welfare (MHLW/PMDA) has approved company’s flagship product, the AngioSculpt Scoring Balloon Catheter. The approval is for the interventional treatment of peripheral artery disease.
“Very few small medical device companies ever gain access to the Japanese market, given that nation’s high performance standards and stringent quality control requirements,” said Thomas R. Trotter, president and CEO of AngioScore. “Today’s announcement is the result of a multi-year joint effort with our marketing partner, USCI Japan, and is a testament to the hard work and dedication of many people in both organizations.”
Michael Van Zandt, President and CEO of USCI Japan, said: “The AngioSculpt PAD approval highlights our two companies’ combined efforts to bring innovative therapies to Japanese physicians and patients, well-aligned with USCI’s future focus on peripheral vascular disease. This approval shows the MHLW/PMDA’s strong efforts to bring safe and effective technologies to Japan in a highly efficient manner.”
Trotter added: “This important approval is the second in Japan for an AngioSculpt catheter and follows the approval of our Coronary catheter in 2008. More than 60,000 AngioSculpt catheters have been shipped worldwide since 2005 with an outstanding overall performance record in the treatment of both coronary and peripheral artery disease.”
The AngioSculpt Scoring Balloon Catheter represents the next generation in angioplasty catheters. Its novel nitinol element provides unique anti-slipping properties while circumferentially dilating plaque, providing a precise and predictable dilatation across a wide range of lesion types. The AngioSculpt provides the versatility and effectiveness of a new technology together with the simplicity and deliverability of a high-performance balloon catheter.