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Roseville, Calif - September 30, 2004.
As many as 80 million people suffer from some form of venous disorder, one of the
most common being varicose veins. Varicose veins are abnormally swollen or
enlarged blood vessels which are caused by a weakening in the vein's wall, which
often leads to pain and swelling in the leg. Fifty to fifty-five
percent of women and forty to forty-five percent of men are affected by this painful
and disfiguring condition and fifty percent of those seek treatment for cosmetic
purposes alone. To meet this vast healthcare need, CoolTouch Inc. announced today
that its CoolTouch CTEV 1320 nm laser system received 510(k) clearance from the
U.S. Food and Drug Administration for the treatment of reflux of the Greater Saphenous
Vein (GSV) associated with varicose veins and varicosities.
The CoolTouch CTEV - Advantages Over Traditional
Varicose Vein Treatments
Historically, varicose veins have been treated by surgically stripping and ligating
the vein or with sclerotherapy. Both of these procedures are associated with
significant pain, patient downtime and potential complications, and their long-term
success is only about 50-60%. According to endovenous expert, Dr. Robert Weiss,
associate clinical professor of dermatology at Johns Hopkins University School of
Medicine, "The approval of the CoolTouch CTEV is great news for patients, physicians
and the healthcare system. Stripping and ligation, which requires hospitalization
and general anesthesia, is fraught with many difficulties. The CoolTouch CTEV
offers patients a virtually pain free, highly successful and cosmetically pleasing
alternative, with a rapid return to normal activity. It will save the healthcare
system a lot of money."
The CoolTouch CTEV procedure takes less than one hour to perform and is done
in an office setting. The patient is awake during the procedure and the leg
is numbed using a tumescent anesthesia. A single small incision is made in
the lower thigh and, guided by ultrasound, a laser fiber is inserted into the GSV.
Once the fiber is in place, the laser is started, contracting the vein wall collagen
and occluding or closing the vein as the fiber is moved through it.
"We are excited to be able to offer patients a truly effective treatment alternative,"
states David R. Hennings, CEO of CoolTouch Inc. "Due to its patient-friendly technology,
it is anticipated that those who avoided treatment before will be more likely to
seek treatment with the CoolTouch CTEV."
The CoolTouch CTEV - Advantages Over Other Endovenous Laser Systems
The CoolTouch CTEV's proprietary 1320 nm wavelength gives it a tremendous advantage
over other endovenous lasers on the market. The unique feature of the 1320
nm wavelength is that it targets collagen in the vein wall and does not interact
with blood. Gentle, controlled heating is used to contract the vein leading to closure.
The shorter wavelengths used by other endovenous lasers target blood for absorption,
generating extremely high temperatures, which can lead to vein ruptures, pain, bruising
and other post-procedure complications.
"The CoolTouch CTEV 1320 nm is the ideal wavelength for this procedure," states
Dr. Weiss. "It is very safe and extremely effective, with a long-term success rate
of 98%. It will be the standard to be beaten by any other technique.
Physicians and patients alike will be greatly impressed when they see the difference
in results between the new CoolTouch 1320 nm laser and the competing 810, 940 and
980 nm laser systems. It is truly the best technology available today."
"With the CoolTouch CTEV, I can relieve my patients' pain and suffering with
a minimally invasive and quick procedure that resolves their problems in a single
event," continues Dr. Weiss. "My patients are ecstatically happy with the results,
and it makes me feel really good to know that we have helped to improve their quality
of life. The more we use the CoolTouch CTEV 1320 wavelength endovenously,
the more we like it."
Through his 24-patient study, Dr. Mitchel Goldman, associate clinical professor
of dermatology at the University of California, San Diego, also determined that
the 1320 nm wavelength was safer than shorter wavelengths used because it does not
interact with the patient's red blood cells, which has been shown to cause perforation
of the vein wall with subsequent post-operative bruising and pain. In his
study, Dr. Goldman used the CoolTouch CTEV 1320 nm endovenous laser to repair or
close the GSV and found it to be a significant breakthrough in the treatment of
varicose veins. "During our 18-month follow-up study of patients treated with
the 1320 nm laser, all patients demonstrated complete closure of the GSV with no
complications or side effects," reported Dr. Goldman. "In fact, the treated vein
was not identifiable by duplex examination six months after treatment, and there
was no recurrence of any varicose veins at any time during our follow-up.
These results demonstrate that the CoolTouch CTEV laser is extremely safe and effective
as a long-term solution in treating varicose veins."
The CoolTouch CTEV is distributed by CoolTouch Inc. in the United States and
GlobalMed Technologies in Europe and Asia (www.globalmedtechnologies.net).
About CoolTouch
CoolTouch Inc., located in Roseville, California, designs, manufactures
and markets light-based aesthetic and medical products with a firm commitment to
continuing innovation and excellent customer service. The first CoolTouch
laser, launched in 1996, incorporated proprietary non-ablative technology with precision-pulsed
cooling and a unique thermal feedback mechanism. CoolTouch® skin treatments
have fast become the gold standard for safe, non-ablative treatment for wrinkles,
acne scars and active acne on all skin types. The CoolTouch VARIAT another
member of the CoolTouch® family of products, provides safe and effective treatment
for hair removal and vascular conditions from small superficial red vessels to deeper
blue and violaceous leg veins.
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