FREMONT, Calif.--(EON: Enhanced Online News)--AngioScore, Inc., a developer of novel angioplasty catheters for use in the treatment of cardiovascular disease, today announced that preliminary data from the First-In-Human (FIH) Study (“PATENT-C”) of the Drug-Coated AngioSculpt Scoring Balloon Catheter will be presented at the Transcatheter Cardiovascular Therapeutics (TCT) Conference in San Francisco the week of October 28, 2013.
This FIH trial of a novel drug-coated scoring balloon catheter enrolled 61 patients with coronary in-stent restenosis (ISR) at five renowned international sites, four in Germany and one in Brazil. The study was led by Bruno Scheller, M.D., Professor of Interventional Cardiology at Saarland University Hospital, Homburg, Germany, who, along with Professor Ulrich Speck of the Charite Hospital in Berlin, is one of the preeminent pioneers in the rapidly developing field of drug-coated balloons for the treatment of coronary and peripheral artery disease.
The drug-coated AngioSculpt FIH study was designed as a randomized controlled trial comparing the recently developed drug-coated AngioSculpt with the commercially available uncoated version of the AngioSculpt in patients presenting with significant restenosis in a previously implanted coronary bare metal stent. Patients underwent follow-up coronary angiography at six months to compare the rate of recurrent restenosis and late lumen loss (LLL) in both treatment arms. Additional study endpoints include the rate of major adverse cardiovascular events (MACE), clinically driven target lesion revascularization (TLR) and stent thrombosis for up to two years following the index procedure. All angiograms were analyzed by an independent core laboratory at the Cardiovascular Research Foundation in New York, N.Y.
The results of the FIM Study will be presented on the following dates and times:
Drug Coated AngioSculpt FIM Clinical Trial Results – “Featured Clinical Research Session” – Dr. Bruno Scheller – Moscone Convention Center West, Room 2002 - 7:45 p.m.
AngioScore Breakfast Symposium - Moscone Convention Center North, Room 121 - 7:00 a.m.
Drug Coated AngioSculpt FIM Clinical Trial Results - “Spotlight Session – Drug Coated Balloons” - Dr. Alexandre Abizaid - Moscone Convention Center North, Room 135 - 9:52 a.m.
The AngioSculpt Scoring Balloon Catheters represent the next generation in angioplasty catheters for both coronary and peripheral artery disease. 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 300,000 procedures worldwide and have achieved an outstanding safety and performance record in the treatment of both coronary and peripheral artery disease.
The Drug-Coated AngioSculpt Scoring Balloon Catheter is an investigational device, limited by applicable law to investigational use and not available for sale.
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.