 |
 |
|
|
 |
 |
 |
 |
 |
 |
 |
| Press Releases |
| Portfolio News |
| JGV in the News |
|
|
||
|
Angioscore Announces Receipt of CE Mark and European Launch of the Angiosculpt Scoring Balloon Catheter
ALAMEDA, CA - September 22, 2004 - AngioScore™, Inc., a developer of novel tools for interventional cardiology, announced today that it has received the CE mark for its flagship AngioSculpt™ scoring balloon catheter. The company will begin shipment of the AngioSculpt scoring balloon catheter to its distributors in Europe in early October. Ephraim Heller, CEO of AngioScore, commented "The AngioSculpt scoring balloon catheter has been approved for routine use in coronary arteries as an alternative to traditional angioplasty balloons. Traditional balloon angioplasty catheters have evolved little over the past 15 years ago and have many limitations. The innovative design of the AngioSculpt scoring catheter and its superb clinical performance provides interventional cardiologists with a long-needed improvement over traditional angioplasty balloons, particularly in patients with complex lesions." Added Prof. Eberhard Grube, Chief of the Department of Cardiology/Angiology at Heart Center Siegburg in Germany: "I recently completed a 15 patient study of the AngioSculpt scoring balloon catheter as part of AngioSculpt's CE mark clinical trial. The catheter performed extremely well in all the patients and lesion types. All patients were treated successfully without complications in-hospital or at follow-up. I was most impressed by the deliverability of the AngioSculpt catheter which was comparable to conventional balloon catheters on the market today and far superior to existing cutting catheters. Our cardiologists were able to easily cross severe stenoses, tortuous anatomies and distal lesions." The AngioSculpt scoring balloon catheter is a line of innovative coronary 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 scoring balloon catheter is intended for the treatment of a hemodynamically significant coronary artery stenosis, including in-stent restenosis, for the purpose of improving myocardial perfusion. The AngioSculpt catheter was developed to address the clinical need for a safe, high performance "workhorse" predilatation catheter that also provides the benefits of plaque scoring in complex cases such as those involving calcified lesions, small vessels and in-stent restenosis. These complex lesions are often characterized by challenging anatomy that makes catheter delivery difficult, balloon slippage leading to "geographic miss", elastic recoil and the need to use high pressures. Combining deliverability comparable to that of high performance angioplasty balloon catheters with the benefits of plaque-scoring and a high rated burst pressure (up to 20 atm), the AngioSculpt catheter is the catheter of choice for complex lesions. Eitan Konstantino, Ph.D., President of AngioScore, remarked: "It is a testament to the experience and talent of the AngioScore team that we are shipping commercial products only a year and a half after incorporation of the company. I am proud to work with this team of successful medical device entrepreneurs and industry veterans." About AngioScore AngioScore, Inc. (www.angioscore.com) is an interventional cardiology company located in Alameda, California. The company's first product is the AngioSculpt scoring 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 the timing of events could differ materially from current expectations and from any forward-looking statements made by the company. Back to Press Releases |
|