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Long-Term
Clinical Studies Conclude VidaMed's TUNA System to be Safe, Effective
and Durable
Five- and Six-Year Studies Presented at AUA
FREMONT, Calif.--(BW HealthWire)--June 5, 2001--VidaMed, Inc. (NASDAQ:VIDA
- news), today reported five- and six-year follow-up data demonstrating
the clinical efficacy of the Company's minimally invasive TUNA (Transurethral
Needle Ablation) System, for the treatment of symptomatic BPH (Benign
Prostatic Hyperplasia, or enlarged prostate).
Alexandre R. Zlotta, M.D., Claude C. Schulman, M.D. and Xenofon Giannakopoulos,
M.D., authored the five-year study, and Dr. Zlotta presented the findings
today at the American Urological Association's (AUA) Annual Meeting underway
in Anaheim, Calif. In this long-term evaluation, 162 consecutive patients
with symptomatic BPH were treated under local anesthesia with TUNA and
were followed for five years in two different centers. The study concluded
that ``TUNA is safe and effective and provides good long-term clinical
improvement at 5 year follow-up. TUNA treatment stands the test of time
with low and acceptable failure rates.''
Jaspal S. Virdi, M.D., Ponnambalam Chandrasekar, M.D. and Faiyaz Kapasi,
M.D., Department of Urology, Princess Alexandra Hospital, Harlow, U.K.
authored the six-year study, and Dr. Chandrasekar presented the findings
today at the AUA Annual Meeting.
The 152-patient, single-site, prospective six-year study concluded that
``TUNA produces minimal morbidity and good patient tolerance.'' No ejaculatory
dysfunction was recorded with TUNA, compared with 76% in TURP. This is
often an important consideration among urologists when choosing the most
suitable method for treating BPH in younger patients. Also, TUNA was found
to be durable - approximately 87% of patients did not need additional
treatment during the six-year trial.
``These long-term studies show the clinical efficacy and durability of
the TUNA procedure and highlight important quality of life benefits for
patients including the maintenance of sexual function,'' stated Randy
Lindholm, chairman, president and chief executive officer of VidaMed.
``In both of these trials the TUNA 2 and TUNA 3 systems were used - state-of-the-art
at the time these two trials were initiated. Today, physicians use our
newest technology, the Precision Office TUNA System, with its full visual
capabilities, 20-minute average treatment times and continuous monitoring
of intra-prostatic temperatures.''
About the 5-Year Study
162 consecutive patients with symptomatic BPH, with a mean prostate size
of 56 gms, were treated with TUNA and were followed for five years in
two different centers. All patients were treated using local anesthesia
only. Pre-operative and five-year follow-up evaluation included urinary
peak flow, International Prostate Symptom Score (IPSS) and post-void residual
urine volume.
About the 6-Year Study
From April 1994 to October 1998, 152 patients with ages ranging from 47
to 87 years (mean 67.5) and with prostatic weights ranging from 20 to
88 gms (mean 43.3) with symptomatic BPH, entered into the trial. Of the
152 patients, 76 were treated by TUNA and 76 were treated with TURP. Assessment
parameters were IPSS, Quality of Life (QOL), uroflow and post-void residual.
About VidaMed
VidaMed designs, develops and markets technologically and clinically advanced
cost-effective systems for the treatment of urological conditions. For
investor information, call 800/363-2994 or visit the Company's Web site
at www.vidamed.com.
Certain statements in this news release contain forward-looking information.
Actual results may vary significantly from those anticipated in such forward-looking
statements due to risks and uncertainties, including the rate of adoption
of the TUNA procedure by the medical community, the impact of competitive
treatments, products and pricing, the development and effectiveness of
the Company's sales organization and marketing efforts, the scope and
level of reimbursement coverage of the TUNA procedure by Medicare and
other payors, and other risks described in the Company's reports filed
from time to time with the United States Securities and Exchange Commission.
The Company's actual results may differ significantly from the results
anticipated by the forward-looking statements as a result of these or
other factors.
Contact:
VidaMed,
Inc.
Randy Lindholm/John Howe, 510/492-4900
www.vidamed.com
or
Lippert Heilshorn & Associates
310/691-7100 (investors)
Bruce Voss
Bvoss@lhai.com
Martin Halsall
Mhalsall@lhai.com
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