News | November 14, 2013

AngioScore Announces Preliminary Clinical Trial Results for World’s First Drug-Coated Scoring Balloon Catheter

balloon catheters cath lab drug-eluting clinical trials angioscore angiosculpt
November 14, 2013 — AngioScore, Inc., a developer of 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 (percutaneous transluminal coronary angioplasty) Scoring Balloon Catheter (PATENT-C) enrolled 61 patients with coronary in-stent restenosis (ISR) at five sites: four in Germany and one in Brazil. Bruno Scheller, M.D., professor of interventional cardiology, Saarland University Hospital, Homburg, Germany led the study.
 
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. An independent core laboratory at the Cardiovascular Research Foundation in New York analyzed all angiograms.
 
The six-month clinical and QCA results from PATENT-C were first presented at the Transcatheter Cardiovascular Therapeutics Conference (TCT 2013) in San Francisco. 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 an 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 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., co-founder and chief medical officer, AngioScore. “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.”
 
AngioSculpt catheters have now been used in more than 300,000 procedures worldwide. 
 
The Drug-Coated AngioSculpt Scoring Balloon Catheter is an investigational device, limited by applicable law to investigational use and not available for sale.
 
For more information: www.angioscore.com

Related Content

Biotronik Studies Demonstrate Efficacy of Minimizing Metal Burden in SFA Therapy
News | Stents Bare Metal| September 22, 2017
Physicians demonstrated that reducing metal burden in superficial femoral artery (SFA) therapy could effectively reduce...
Edwards Inspiris Resilia Valve Receives FDA Approval
News | Heart Valve Technology| September 21, 2017
Edwards Lifesciences Corp. recently received U.S. Food and Drug Administration (FDA) approval for its Inspiris Resilia...
MyoKardia Presents Additional Positive Data From Phase 2 PIONEER-HCM Study at HFSA 2017
News | Heart Failure| September 21, 2017
MyoKardia Inc. announced that additional positive data from the first patient cohort of its Phase 2 PIONEER-HCM study...
Tryton Side Branch Stent Recognized With Premier Technology Breakthrough Award
News | Stents Bifurcation| September 21, 2017
September 21, 2017 — Cardinal Health and Tryton Medical Inc.
DISRUPT BTK Study Shows Positive Results With Lithoplasty in Calcified Lesions Below the Knee
News | Peripheral Artery Disease (PAD)| September 20, 2017
Shockwave Medical reported positive results from the DISRUPT BTK Study, which were presented at the annual...
Corindus Announces First Patient Enrolled in PRECISION GRX Registry
News | Robotic Systems| September 18, 2017
September 18, 2017 — Corindus Vascular Robotics Inc.
Two-Year ILLUMENATE Trial Data Demonstrate Efficacy of Stellarex Drug-Coated Balloon
News | Drug-Eluting Balloons| September 18, 2017
Philips announced the two-year results from the ILLUMENATE European randomized clinical trial (EU RCT) demonstrating...
Sentinel Cerebral Protection System Significantly Reduces Stroke and Mortality in TAVR
News | Embolic Protection Devices| September 18, 2017
September 18, 2017 – Claret Medical announced publication of a new study in the...
Fysicon Receives FDA Approval for QMAPP Hemodynamic Monitoring System
Technology | Hemodynamic Monitoring Systems| September 18, 2017
Fysicon announced that it has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its...
Marijuana Associated With Three-Fold Risk of Death From Hypertension
News | Hypertension| September 14, 2017
Marijuana use is associated with a three-fold risk of death from hypertension, according to research published recently...
Overlay Init