AngioScore Announces PMA Supplement Approval Allowing a Summary of the AGILITY Coronary Bifurcation Trial Results in the AngioSculptï¿½ IFU
FREMONT, Calif.--(BUSINESS WIRE)--
,a developer of novel angioplasty
catheters for use in the treatment of cardiovascular disease, today
announced that the FDA has approved a Pre-market Approval Supplement
(PMAS) labeling change allowing inclusion of a summary of the AGILITY
Coronary Bifurcation Trial results in the AngioSculpt® PTCA Scoring
Balloon Catheter Instructions for Use (IFU).
The AGILITY trial enrolled 93 patients with complex true coronary
bifurcation lesions at nine premier interventional cardiology programs
in the U.S. and followed these patients for nine months. Jeffrey Moses,
M.D., Professor of Medicine at Columbia University Medical Center,
served as the overall trial Principal Investigator: The AngioSculpt®
Scoring Balloon represents a significant advance in the treatment of
complex coronary lesions. Coronary artery bifurcation lesions represent
20% to 25% of the more than 800,000 percutaneous interventions performed
annually in the United States, with approximately 60% of these being the
more complex true bifurcations. I am delighted to have led this
important study and am honored that such a prominent group of
interventional cardiologists participated in this trial.
The AngioSculpt® represents an alternative to conventional balloon
angioplasty catheters for the treatment of challenging lesions because
of its ability to achieve predictable luminal expansion and a low rate
of dissection. The results of the prospective multi-center AGILITY trial
(ClinicalTrials.gov Identifier: NCT 00686647) demonstrate that use of
the AngioSculpt® was associated with a high rate of procedural success
(91.4%); a low need for bailout stenting of the side-branch vessel
(10.9%); and a very low rate of target lesion revascularization (TLR) at
nine months follow-up, with only one of the 93 patients (1.1%)
experiencing TLR after 30 days. It is significant that the FDA has now
allowed the company to present certain AGILITY trial results relating to
bifurcations in its Instructions for Use, said Gary Gershony, M.D.,
Co-Founder and Chief Medical Officer of AngioScore.
In January 2007, the AngioSculpt® Percutaneous Transluminal Coronary
Angioplasty (PTCA) Scoring Balloon Catheter received FDA Pre-market
Approval (PMA) for the treatment of hemodynamically significant coronary
artery stenosis, including in-stent restenosis and complex type C
lesions, for the purpose of improving myocardial perfusion. Approval of
the recent PMAS allows a labeling change with addition of certain
AGILITY bifurcation trial results to the IFU. The indications for use
for the device remain unchanged.
The AngioSculpt® Scoring Balloon Catheters represent the next generation
in angioplasty catheters for both coronary and peripheral artery
disease. Their innovative nitinol elements provide unique
circumferential scoring of plaque, leading to precise and predictable
luminal enlargement across a wide range of lesion types while avoiding
geographic miss through their unique anti-slippage properties. The
AngioSculpt® catheters provide the versatility and effectiveness of a
new technology together with the simplicity and deliverability of
traditional high-performance balloon catheters.
AngioSculpt® catheters have now been used in more than 250,000
procedures worldwide and have achieved an outstanding performance record
in the treatment of both coronary and peripheral artery disease.
Note: This press release contains forward-looking statements that are
based upon managements current expectations and are inherently
uncertain. Actual results and timing of events could differ materially
from current expectations and forward-looking statements.
AngioScore, Inc.Gary Gershony, M.D.Chief Medical Officer(510)
Source: AngioScore, Inc.