US-based AngioScore has presented six-month clinical and quantitative coronary angiography results from the first-in-human (FIH) clinical trial of its drug-coated AngioSculpt PTCA scoring balloon catheter at the Transcatheter Cardiovascular Therapeutics Conference in San Francisco during the week of 28 October 2013.
This FIH clinical study (PATENT-C) has enrolled 61 patients with coronary in-stent restenosis (ISR) at four sites in Germany and one site in Brazil.
The randomized, controlled, drug-coated AngioSculpt FIH study has been designed to compare 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.
For comparing the rate of recurrent restenosis and late lumen loss in both treatment arms, patients underwent follow-up quantitative coronary angiography at six months.
The study endpoints also included the rate of major adverse cardiovascular events, clinically driven target lesion revascularization, and stent thrombosis for up to two years following the index procedure.
Overall, the clinical trial has met the primary efficacy endpoint.
AngioScore co-founder and chief medical officer Dr Gary Gershony noted 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.
"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," Dr Gershony added.
The AngioSculpt scoring balloon catheters provide the versatility and effectiveness of a new technology together with the simplicity and deliverability of traditional high-performance balloon catheters.
These catheters have been used in over 300,000 procedures across the globe and have achieved an outstanding safety and performance record in the treatment of both coronary and peripheral artery disease.
The AngioSculpt PTCA scoring balloon catheter is an investigational device and is not available for sale.