Study Data Shows VNUS ClosureFAST(TM) Catheter More than 96% Effective

Sat Feb 23, 2008 3:00pm EST
 
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Distinguished Physicians' Panel at American Venous Forum Presents Clinical
Trial Results Confirming Efficacy, Greater Patient Comfort Than Laser

SAN JOSE, Calif., Feb. 23 /PRNewswire-FirstCall/ -- VNUS(R) Medical
Technologies, Inc. (Nasdaq: VNUS), a worldwide leader in medical devices for
the minimally invasive treatment of venous reflux disease, today presented
positive clinical performance data for the VNUS ClosureFAST(TM) catheter at
the 20th annual meeting of the American Venous Forum in Charleston, South
Carolina.  An international panel of distinguished physicians presented
clinical trial results and perspectives affirming the efficacy and patient
comfort levels of endovenous radiofrequency (RF) vein ablation using VNUS
ClosureFAST.  The ClosureFAST catheter, in a procedure often performed in the
physician's office, heats and seals the diseased leg veins that cause the
varicose veins afflicting more than 25 million Americans.
Prof. Dr. Thomas M. Proebstle of Heidelberg, Germany presented one-year
followup data from a prospective, multi-center study of the efficacy of the
ClosureFAST catheter.  Raymond G. Makhoul, M.D., of Richmond, Virginia
presented results from the RECOVERY trial, a single-blinded, randomized trial
comparing the ClosureFAST catheter with endovenous laser ablation in 62 limbs.
    "Our study found the ratio of efficacy to side effects of the VNUS
ClosureFAST catheter to be superior to any previous endovenous ablation
device," said Dr. Proebstle. "In 223 cases where the ClosureFAST device was
used, 96.7% of the veins remained sealed after one year using Kaplan-Meier
analysis. Of my patients, only one in five experienced postoperative pain due
to study treatment. The excellent clinical outcome, the speed of treatment and
the very low rate of side effects are certainly contributing to the
enthusiastic embrace of this new device by the physician community."
    "Our RECOVERY trial data makes it clear that radiofrequency vein ablation
with the ClosureFAST device is superior to laser ablation in terms of patient
comfort and satisfaction," said Dr. Makhoul.  "27% of the ClosureFAST patients
reported that the procedure itself was completely pain-free, compared with
just 3% of the laser patients, and the need for postoperative analgesics was
lower with ClosureFAST patients than with laser patients.  We believe that the
increased patient satisfaction with ClosureFAST is serving as a strong
incentive for vascular physicians to transition to the ClosureFAST catheter
from previous devices."
    "The ClosureFAST device has significantly improved endothermal ablation
with a smooth, deliberate, controlled and much swifter technique," said Robert
F. Merchant, M.D., of Reno, Nevada, who has been performing RF vein ablation
since 1999.  "With some simple but elegant modifications to the
technique -- proper positioning of the catheter away from the deep vein
system, elevation of the leg -- we've been able to produce an even lower rate
of complications and make the procedure even easier for the physician."
    "Endovenous ablation of the great saphenous vein has revolutionized the
way that we care for the venous patient," said Thomas F. O'Donnell Jr., M.D.,
of Boston, Massachusetts, who moderated the physicians' panel. "In our own
practice I have seen confirmation of the results from Dr. Proebstle's multi-
center ClosureFAST trial that this newer generation catheter is faster and
easier to use.  And the evidence-based results from the randomized,
prospectively controlled trial by Dr. Makhoul and his colleagues confirms
anecdotal experience that the RF catheter appears to be kinder and gentler
without sacrificing effective durable closure rates."
    "We believe the findings presented by the physicians paint a compelling
picture of the VNUS ClosureFAST catheter as the new treatment of choice for
patients who suffer from the pain, swelling and discomfort of varicose veins,"
said Brian E. Farley, President and CEO of VNUS. "The documented efficacy of
the device and the overwhelmingly positive responses of physicians and
patients regarding its ease of use, comfort and mild recovery are driving the
rapid adoption of the ClosureFAST catheter, resulting in substantial benefits
to varicose vein patients in over 40 countries."
    ABOUT VNUS MEDICAL TECHNOLOGIES, INC.
    Founded in 1995 and headquartered in San Jose, California, VNUS Medical
Technologies (Nasdaq: VNUS) is a worldwide leader in medical devices for the
minimally invasive treatment of venous reflux disease, a progressive condition
that causes the varicose veins afflicting 25 million Americans. The pioneering
company in the field, VNUS now offers the ClosureFAST 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. VNUS devices have been used
in more than 200,000 procedures worldwide. For more information, please visit
www.vnus.com.
    FORWARD-LOOKING STATEMENTS
    In addition to statements of historical facts or statements of current
conditions, VNUS has made forward-looking statements in this press release.
Words such as "thinks" or "believes" or variations of such words and similar
expressions, are intended to identify such forward-looking statements in this
press release. Actual results may differ materially from current expectations
based on a number of factors affecting VNUS' business, including, among other
things, market acceptance of the ClosureFAST catheter, customer and physician
preferences, and the experience of other physicians with our products. The
reader is cautioned not to unduly rely on these forward-looking statements.
VNUS expressly disclaims any intent or obligation to update these forward-
looking statements except as required by law.
Additional information concerning these and other risk factors can be found in
press releases issued by VNUS and VNUS' periodic public filings with the
Securities and Exchange Commission (SEC), including its Annual Report on Form
10-K filed with the SEC on March 30, 2007. Copies of VNUS' press releases and
additional information about VNUS are available on the corporate website at
www.vnus.com.
SOURCE  VNUS Medical Technologies, Inc.

Jon Kitahara, Director, Marketing Programs, +1-408-360-7220,
jkitahara@vnus.com

 

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