AngioScore, Inc. Announces PMA Supplement Approval Allowing a Summary of the AGILITY Coronary Bifurcation Trial Results in the AngioSculpt® IFU
6/12/2013 10:55:48 AM
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FREMONT, Calif.--(BUSINESS WIRE)--AngioScore, Inc., 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.”
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