FOR IMMEDIATE RELEASE
For More Information, Contact:
Leslie Newman (916) 677-1934
COOLTOUCH CTEV 1320 NM LASER GETS FDA CLEARANCE FOR
ENDOVENOUS TREATMENT OF THE GREATER SAPHENOUS VEIN.
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.”
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CoolTouch CTEV FDA/Page 2
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 postoperative 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 nonablative 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 VARIA,
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.
For more information, please visit our Website at www.cooltouch.com.
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