Healthcare Industry News: saphenous vein
News Release - June 5, 2006
VNUS Medical Technologies Reports First Human Experience With New ClosureFAST(TM) CatheterNew Endovenous Radiofrequency Ablation Catheter is Intended to Reduce Procedure Time While Preserving Favorable Patient Outcomes and Comfort
SAN JOSE, Calif., June 5 (HSMN NewsFeed) -- VNUS® Medical Technologies, Inc. (Nasdaq: VNUS ), a leading provider of medical devices for the minimally invasive treatment of venous reflux disease, announced today that over 30 patients have been successfully treated with the VNUS ClosureFAST(TM) catheter at three centers in Europe. All patients were treated under local anesthesia and 100% of treatments were successful at occluding the great saphenous vein both acutely and at a three day post-procedure ultrasound examination.
The VNUS ClosureFAST catheter is designed to heat, shrink, and occlude refluxing saphenous veins with RF ablation times of just three to five minutes, a goal achieved in all of the patients treated to date with the new device. The ClosureFAST catheter is designed to be compatible with the current VNUS RFG Plus(TM) radiofrequency generator, requiring only a software upgrade which the company expects can be quickly performed in the field.
"VNUS is very pleased to provide this preliminary report of successful human clinical experience with the new ClosureFAST catheter. These initial results indicate that this product can significantly speed up procedure time while also providing patients the RF treatment benefit of rapid recovery with minimal or no discomfort," stated VNUS Medical Director and Vice President of Clinical Research, Lian X. Cunningham, M.D., Ph.D.
Like the original VNUS Closure® catheter, the new ClosureFAST catheter controls vein wall temperature during treatment, and is designed to avoid the vein perforations and related post-procedure pain and bruising that are commonly associated with endovenous laser treatment.
"We are encouraged by these early results and will continue to accumulate additional clinical experience on our way to seeking marketing clearance of the product. With continuing clinical success, we look forward to the commercial launch of this product in the U.S. and other markets in 2007," stated VNUS President and CEO, Brian E. Farley.
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® 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 www.vnus.com.
VNUS has made forward-looking statements in this press release within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Words such as "plans," "looks forward to," "intends," "expect" and "potential" or variations of such words, are intended to identify such forward-looking statements in this press release. These statements are based on information available to VNUS as of the date of this press release and represent VNUS' judgment only as of the date of this press release. Actual results may differ materially from current expectations based on a number of factors, including, among other things, the failure to achieve favorable clinical outcomes over a longer term or in a larger group of patients, or a delay in or inability to obtain marketing clearance from the U.S. Food and Drug Administration for sale of the ClosureFAST device. Therefore, the reader is cautioned not to rely on these forward-looking statements. VNUS expressly disclaims any intent or obligation to update these forward-looking statements except as required by law.
Source: VNUS Medical Technologies
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