AngioScore, Inc., a developer of novel angioplasty catheters for use in the treatment of cardiovascular disease, announced detailed preliminary clinical trial results for the world's first drug-coated scoring balloon catheter.
This First-in-Human (FIH) trial of a novel drug-coated AngioSculpt PTCA Scoring Balloon Catheter, known by the acronym PATENT-C, 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 PATENT-C 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 quantitative coronary angiography (QCA) at six months to compare the rate of recurrent restenosis and late lumen loss (LLL) in both treatment arms. Additional study endpoints included 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 six-month clinical and QCA results from PATENT-C were first presented at the Transcatheter Cardiovascular Therapeutics (TCT) Conference in San Francisco during the week of October 28, 2013. Overall, the trial easily met the primary efficacy endpoint with an in-segment LLL of 0.14±0.4 mm and 0.47±0.51 mm for the drug-coated and uncoated AngioSculpt groups respectively (p<0.05). This was even more significant when the patients were evaluated according to the actual treatment received, with the drug-coated AngioSculpt group achieving a remarkable in-segment LLL of 0.07±0.24 mm (p<0.01). These angiographic findings were paralleled by a marked reduction in adverse events, including clinically driven TLR, in the drug-coated AngioSculpt treated patients. "The six-month results of the PATENT-C Trial are impressive and appear to be among the best angiographic and clinical outcomes available to-date for the emerging field of drug-coated balloons," said Gary Gershony, M.D., AngioScore Co-Founder and Chief Medical Officer. "The development of a drug-coated AngioSculpt Scoring Balloon Catheter has the potential to become a disruptive new technology for the treatment of complex coronary and peripheral artery disease."
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.
About AngioScore
AngioScore, Inc (www.angioscore.com) is a privately funded endovascular company located in Fremont, California. 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.
Contacts:
AngioScore, Inc.
Gary Gershony, M.D.
Chief Medical Officer
510-933-7902
