AngioScore Obtains Japanese Approval for AngioSculpt Scoring Balloon Catheter
AngioScore, Inc., a developer of novel angioplasty catheters for
use in the treatment of cardiovascular disease, announced today that
its flagship product, the AngioSculpt(R) 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 (www.usci.co.jp) is a USCI Holdings
(www.usciholdings.com) member company with headquarters in Tokyo,
Japan. MC (www.welcome-mc.co.jp) and MedCare (http://www.medocare.net)
are also USCI Holdings member companies. USCI Japan can be contacted
at +81-3-3578-7780.
About AngioScore
AngioScore, Inc (www.angioscore.com) 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
Note: This press release contains forward-looking statements that
are based upon management´s current expectations and are inherently
uncertain. Actual results and timing of events could differ materially
from current expectations and forward-looking statements.