Healthcare Industry News:  saphenous vein 

Devices FDA

 News Release - November 16, 2006

The CoolTouch CTEV(TM) Endovenous Laser Now Approved to Treat Tributary Veins

ROSEVILLE, Calif., Nov. 16 (HSMN NewsFeed) -- CoolTouch Inc., a leading manufacturer of medical lasers since 1994, announced today that the CoolTouch CTEV 1320 nm laser system received 510(K) clearance from the U.S. Food and Drug Administration for the treatment of superficial incompetent tributary veins associated with varicose veins and varicosities. This approval confirms the CoolTouch CTEV is a safe and effective laser treatment for the treatment of incompetent tributaries and the reflux of the Great saphenous vein (GSV) and Small saphenous vein (SSV).

"CoolTouch is excited to receive the first tributary FDA approval," states David R. Hennings, CEO of CoolTouch Inc. "Preliminary studies have proven the CTEV as an effective method to treat tributaries; the FDA approval confirms it is a safe and effective method of treatment."

Dr. Robert Weiss, associate clinical professor of dermatology at John Hopkins University School of Medicine, recently conducted a preliminary study to determine the efficacy of the CTEV laser for treatment of the tributary vein.

"My preliminary study results indicate the CoolTouch CTEV is the superior technology for tributary vein treatment," says endovenous expert Dr. Robert Weiss "The 1320 laser provides a more controlled energy delivery, which is an important factor when treating the smaller veins such as the tributaries."

The CoolTouch CTEV 1320 nm nd:YAG endovenous laser mechanism of action targets water in the vein wall, which allows it to successfully close the affected vein(s) more efficiently than other endovenous lasers whose mechanism of action is hemoglobin. The CTEV's targeted energy delivery results in a more comfortable procedure for the patient without sacrificing its procedural effectiveness.

About CoolTouch

CoolTouch Inc. located in Roseville, California designs, manufacturers and markets light-based aesthetic and medical products with a firm commitment to continuing innovation and excellent customer service. The CoolTouch Nd:YAG product line includes: The CoolTouch CT3PLUS(TM) 1320 nm, the gold standard for safe, non-ablative treatment for wrinkles, acne scars and active acne for all skin types; The CoolTouch VARIA(TM) 1064 nm, providing safe and effective treatment for hair removal and vascular conditions; and the CoolTouch CTEV(TM) 1320 nm endovenous laser for treatment of varicose veins. In September 2006, CoolTouch was named the fifth fastest growing company in the Sacramento, California area by the Sacramento Business Journal. The list is ranked by increased growth percentage from year to year. CoolTouch has been on the Sacramento Business Journal's fastest growing company list for six years.

The CoolTouch laser products are distributed in the United States by CoolTouch Inc. and internationally through various distribution channels.

For more information please visit .

Source: CoolTouch

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