News | October 22, 2013

AngioScore to Present Data From First-In-Human Study of the Drug-Coated Scoring Balloon at TCT

balloon catheters cath lab clinical trial study angioscore angiosculpt scoring
October 22, 2013 — AngioScore Inc., a developer of angioplasty catheters for use in the treatment of cardiovascular disease, 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 Oct. 28.
This FIH trial enrolled 61 patients with coronary in-stent restenosis (ISR) at five international sites: four in Germany and one in Brazil. Bruno Scheller, M.D. and professor of interventional cardiology at Saarland University Hospital, Homburg, Germany, led the study, and along with Ulrich Speck of the Charité Hospital in Berlin, is one of the 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 City.
The results of the FIM Study will be presented on the following date and times:
  • Oct. 28, 7:45 p.m. — Drug-coated AngioSculpt FIM Clinical Trial Results, “Featured Clinical Research Session,” Bruno Scheller — Moscone Convention Center West room 2002
  • Oct. 30, 7:00 a.m. — AngioScore Breakfast Symposium, Moscone Convention Center North room 121
  • Oct. 31, 9:52 a.m. — Drug-coated AngioSculpt FIM Clinical Trial Results - “Spotlight Session – Drug Coated Balloons,” Alexandre Abizaid, Moscone Convention Center North room 135
The AngioSculpt Scoring Balloon Catheter is an investigational device limited by applicable law to investigational use and not available for sale.
For more information:

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