AngioScore Obtains Japanese Approval For AngioSculpt Scoring Balloon Catheter

Main Category: Cardiovascular / Cardiology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 30 Jan 2008 - 4:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

AngioScore, Inc., a developer of novel angioplasty catheters for use in the treatment of cardiovascular disease, announced that its flagship product, the AngioSculpt® Scoring Balloon Catheter, has received import approval from Japan's Ministry of Health, Labor and Welfare (MHLW/PMDA) for the interventional treatment of coronary artery disease in that country.

AngioScore and USCI Japan, a prominent distributor of medical devices in Japan, have collaborated for several years to achieve this critically important milestone. Japan represents a major market opportunity for AngioScore, second only to the United States in the number of cardiovascular procedures performed on an annual basis.

"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. 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, USCI Japan CEO, added, "Japanese physicians are keenly interested in utilizing the best medical technology, and the AngioSculpt represents a truly innovative advancement for improving patient quality of life. This is our first MHLW/PMDA submission under Japan's new Pharmaceutical Affairs Law. We are pleased with the Japanese government's progress in helping patients gain access to new therapies. 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."

Added Trotter: "With more than 180,000 interventional procedures being done in Japan annually, we believe that the AngioSculpt will quickly gain a significant market presence. More than 10,000 AngioSculpt catheters have been used worldwide and have an outstanding 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 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.

About USCI Japan

USCI Japan, Ltd is a USCI Holdings member company with headquarters in Tokyo, Japan. MC and MedCare are also USCI Holdings member companies.

About AngioScore

AngioScore, Inc is a privately funded endovascular company located in Fremont, California. The company's first product is the AngioSculpt Scoring Balloon Catheter. AngioScore can be contacted at (510) 933-7900 or info@angioscore.com

USCI Japan