AngioScore, Inc, a Fremont, California firm, has received import approval from Japan’s Ministry of Health, Labor and Welfare for its AngioSculpt® Scoring Balloon Catheter, a device first covered by us back in October 2007. This novel angioplasty catheter is designed to perform without balloon slippage during the procedure. The device is awaiting an OK from the FDA, for now holding on to the Pre-Market Approval (PMA) application that the FDA has confirmed back in January 2007. The device is approved for marketing in the European Union.
From the press release:
“We are extremely pleased to have accomplished this critically important milestone,” said Thomas R. Trotter, president and CEO of AngioScore. “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…"
The AngioSculpt Scoring Balloon Catheter represents 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. The AngioSculpt provides the versatility and effectiveness of a new technology together with the simplicity and deliverability of a high-performance balloon catheter.
Press release: AngioScore Obtains Japanese Approval for AngioSculpt Scoring Balloon Catheter …
Product page: AngioSculpt Scoring Balloon Catheter …
Flashback: AngioSculpt® Scoring Balloon Catheter
