ALAMEDA, Calif., March 24 /PRNewswire/ -- AngioScore, Inc., a developer of novel angioplasty tools for interventional cardiologists and radiologists, announced today the completion of the US clinical trial for it’s flagship AngioSculpt Scoring Balloon Catheter in coronary lesions and the conclusion of follow up on the 200 patients in the trial. The clinical trial was led by study principal investigator Dr. Martin Leon of Columbia University and conducted at nine centers including Brigham and Women’s Hospital, Columbia University, Minneapolis Heart Institute, Scripps Clinic, Stanford University Medical Center, Swedish Medical Center, University of Oklahoma, Washington Adventist, and Washington Hospital Center.
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The US clinical trial is a prospective clinical study of the safety and efficacy of the AngioSculpt scoring balloon catheter in 200 patients undergoing angioplasty to treat coronary artery disease. The study examines acute outcomes when the AngioSculpt scoring balloon catheter is used for the treatment of a hemodynamically significant coronary artery stenosis, including in-stent restenosis, for the purpose of improving myocardial perfusion.
Commented Principal Investigator Martin Leon, MD, Associate Director of Cardiovascular Interventional Therapy at Columbia University Medical Center and Chairman of the Cardiology Research Foundation, “We are extremely pleased with the rapid enrollment of 200 patients in this trial within 4 months of initiation. The AngioSculpt Scoring Balloon Catheter is a promising new approach to dilatation of challenging lesions and potentially a valuable adjunct to drug eluting stents, facilitating precise stent placement and complete expansion.”
Added Gary Gershony, MD, AngioScore’s Chief Medical Officer, “The AngioSculpt Scoring Balloon Catheter may provide significant advantages over existing angioplasty catheters in dealing with complex lesions. The device is designed to enable dilatation of fibrocalcific lesions at lower pressure and to reduce ‘geographic miss’ due to slipping of traditional angioplasty balloons. The AngioSculpt Scoring Balloon Catheter scores plaques without using the sharp blades or cutters that are employed in competitive devices such as those from Boston Scientific and FoxHollow Technologies and has the potential to improve outcomes in more than half of the 2.2 million coronary angioplasties performed annually worldwide.”
The AngioSculpt scoring balloon catheter is a line of innovative coronary and peripheral angioplasty catheters comprising an angioplasty balloon surrounded by a unique system of nitinol scoring elements. Creating focal concentrations of dilating force, the scoring elements score arterial lesions as the balloon expands. The AngioSculpt catheter was developed to address the clinical need for a safe, high performance predilatation catheter that also provides the benefits of plaque scoring in complex coronary cases such as those involving calcified lesions, ostial lesions, small vessels, and in-stent restenosis. Combining catheter deliverability with the benefits of plaque- scoring and a high rated burst pressure (up to 20 atm), the AngioSculpt Scoring Balloon Catheter will be a valuable tool for complex lesions.
About AngioScore
AngioScore, Inc. (http://www.angioscore.com/) is an endovascular therapy company located in Alameda, California. The company’s first product is the AngioSculpt Scoring Balloon Catheter. AngioSculpt is an investigational device in the United States. AngioScore can be contacted at +1-510-263-0480 or info@angioscore.com.
This press release contains forward-looking statements that are based upon management’s current expectations and are inherently uncertain. Forward- looking statements are based upon information available to us as of the date of this press release and we assume no obligation to revise or update any such forward-looking statement to reflect any event or circumstance after the date of this release. Actual results and timing of events could differ materially from current expectations and from any forward-looking statements made by the company.
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CONTACT: Nick Fravala, VP of Sales and Marketing of AngioScore,+1-510-263-0480, ext. 114
Web site: http://www.angioscore.com/