Whoops, I forgot the press release, here it is.
Ed
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Laserscope receives FDA clearance for new higher-power surgical
laser system
Business Wire - June 11, 1997 07:59
LASERSCOPE LSCP %CALIFORNIA %MEDICINE %PHARMACEUTICAL %BIOTECHNOLOGY %PRODUCT V%BW P%BW
Jump to first matched term
SAN JOSE, Calif.--(BW HealthWire)--June 11, 1997--Laserscope (NASDAQ:LSCP) today announced that it
received clearance from the U.S. Food and Drug Administration (FDA) to market a new, higher-power version of its
800 Series Dual-Wavelength KTP/YAG(R) Surgical Laser System.
"We believe that the new higher-power system will add to the efficiency of a number of surgical procedures. To our
knowledge, no one else has been able to technically achieve KTP laser energy at the power levels that our R&D design
team has successfully attained," said Robert V. McCormick, Laserscope President & CEO.
The new configuration boosts KTP energy levels to 50 watts and delivers 100 watts of Nd:YAG energy. The system
has applications in gynecology, plastic surgery, thoracic surgery, and especially in urology.
A new study by researchers at the Mayo Clinic using the new higher-power system, reported in the May 1997 issue of
the medical journal Urology, concludes: The higher-power KTP laser "allows technically easy, safe, rapid, and
hemostatic removal of canine prostatic tissue in vivo. Furthermore, there is no difference in the efficacy of KTP laser
vaporization between human and canine cadaver prostates. These findings suggest that KTP laser vaporization may be
as effective in living human prostates as it is in living dogs, and thus it may be a useful technique in the surgical
treatment of human benign prostatic hyperplasia."
The study, entitled "High-Power Potassium-Titanyl-Phosphate Laser Vaporization Prostatectomy in Living Canines
and in Human and Canine Cadavers," also noted that the higher-power KTP laser procedure "technically appears to be
as simple as electrosurgical techniques and gives the operator excellent visual control over precisely which tissue is
removed and which tissue is left intact. In other words, with KTP laser vaporization, what one sees is very nearly what
one gets... (Higher-power KTP laser vaporization) appears to be a very user-friendly laser prostatectomy technique and
deserves serious consideration in humans."
The study was authored by Randall S. Kuntzman, M.D., Reza S. Malek, M.D., David M. Barrett, M.D., and David
G. Bostwick, M.D. of the Department of Urology and Section of Surgical Pathology at the Mayo Clinic in Rochester,
Minn.
It has been estimated that more than 25 million men worldwide exhibit some symptoms of BPH, of which 3 million
will probably seek some form of medical treatment.
Laserscope's 800 Series KTP/YAG Surgical Laser System is designed for the hospital market. It is a dual-wavelength
system that can surgically cut, vaporize and coagulate tissue without disruption to adjacent areas. The new
higher-power configuration is expected to be available in the fall as a field upgrade to approximately 1,000 installed
Laserscope 800 Series Surgical Laser Systems throughout the world.
Laserscope designs, manufactures, sells and services on a worldwide basis an advanced line of medical laser systems
and related energy delivery devices for the office, outpatient surgical center and hospital markets. Laserscope's Ascent
Medical Systems (AMS) family of products includes operating and treatment room lights, ceiling-mounted equipment
organizers, video systems, operating room tables and centralized smoke evacuation systems.
Statements in this announcement about future results are preliminary and based on partial information and assumptions.
Except for the historical information presented, the matters discussed in this announcement contain forward-looking
statements that involve risks and uncertainties, including the ability to introduce new products successfully, the
development and rate of growth of new and existing procedures and markets, the impact of competitive procedures,
technologies and products, and other risks detailed from time to time in the company's public disclosure filings with the
U.S. Securities and Exchange Commission (SEC). Copies of the company's most recently filed Forms 10K and 10Q
are available from Laserscope's Investor Relations Department.
CONTACT: Laserscope
Richard Wood (IR/Media), 408/943-0636
Dennis LaLumandiere (Financial), 408/943-0636
or
Hilary Kaye Associates
Hilary Kaye/Shelle Murach, 714/851-5150 |
