Clinical Trial Results Of VNUS ClosureFAST(TM) Catheter Presented At American Venous Forum Meeting

Main Category: Vascular
Also Included In: Medical Devices / Diagnostics;  Radiology / Nuclear Medicine;  Clinical Trials / Drug Trials
Article Date: 24 Feb 2007 - 0:00 PDT

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VNUS(R) Medical Technologies, Inc. (Nasdaq: VNUS), a leading provider of medical devices for the minimally invasive treatment of venous reflux disease, announced today that Prof. Dr. Thomas Proebstle of the University of Heidelberg, Germany, presented the first report of six-month follow-up clinical results from a multi-center clinical trial of the new ClosureFAST endovenous radiofrequency (RF) vein ablation catheter at last week's American Venous Forum meeting in San Diego, CA.

The VNUS ClosureFAST catheter is designed to heat, shrink and occlude refluxing saphenous veins with RF ablation times of just three to five minutes while maintaining the fast and mild patient recovery that physicians expect with RF vein ablation.

Dr. Proebstle reported on 252 limbs in 194 patients with saphenous vein reflux who were treated with the VNUS ClosureFAST radiofrequency catheter. The patients were treated at eight centers in Germany and France from April through November 2006. One hundred sixty four limbs had 3 months follow-up data and 62 limbs had 6 months follow-up data. Vein occlusion rate was 100% at 3 and 6 months. The largest veins treated were 18 mm in diameter. No serious complications such as deep venous thrombosis or thermal skin injury were observed in any patients in the study.

"ClosureFAST provides the ability to deliver high-energy dosage to obtain a successful treatment but almost totally without the disturbing side effects of laser. After my first 100 cases I find these initial results very encouraging and look forward to expanding my use of this product," said Prof. Dr. Proebstle.

Living up to its name, treatments with the ClosureFAST catheter resulted in an average energy delivery time of 2.2 minutes and the average procedure time (measured from catheter insertion to catheter removal, including the time for the administration of tumescent anesthesia) was 16.4 minutes.

"Feedback from physicians has been extremely positive on the performance, the speed, and the ease of use of the catheter," stated the company's Medical Director and Vice President of Clinical Research, Lian X. Cunningham, M.D., Ph.D. "In addition, ClosureFAST catheter investigators reported that the patient recovery profile has been rapid and mild as expected with radiofrequency ablation."

Like the original VNUS Closure(R) catheter, the new ClosureFAST catheter monitors treatment temperature and controls energy delivery. It is designed to avoid the vein perforations and related post-procedure pain and bruising that are commonly associated with endovenous laser treatment.

ABOUT VNUS MEDICAL TECHNOLOGIES, INC.

VNUS Medical is a leading provider of medical devices for the minimally invasive treatment of peripheral vascular disease, including venous reflux, a progressive condition caused by incompetent vein valves in the leg. VNUS sells the Closure(R) system, which consists of a proprietary radiofrequency (RF) generator and proprietary disposable endovenous catheters and devices to close diseased veins through the application of temperature-controlled RF energy. For more information, please visit the corporate website at http://www.vnus.com.

VNUS Medical Technologies, Inc.
http://www.vnus.com

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