PMA Supplement Approval Means AngioSculpt® IFU can Include Clinical Trial Results

AngioSculpt Scoring BalloonAngioplasty catheter developer, AngioScore, Inc., has announced the FDA approval of 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).

Background

AngioScore says its AngioSculpt® Scoring Balloon Catheters represent the next generation in angioplasty catheters for both coronary and peripheral artery disease. The “Scoring” bit comes from innovative nitinol elements (see image), which 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.

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 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.

Investigator comments

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.”

Company comments

“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.

Source: AngioScore, Inc., Business Wire