Healthcare Industry News:  Intravascular Temperature Management 

Devices FDA

 News Release - August 26, 2008

Alsius Corporation Receives 510(K) Market Clearance for Solex(TM) Catheter

New Heat Exchange Catheter Offers Clinicians More Patient Treatment Options

IRVINE, Calif., Aug. 26 (HSMN NewsFeed) -- Alsius Corporation (Nasdaq: ALUS ), the worldwide leader in Intravascular Temperature Management (IVTM(TM)) therapies, today announced that the U.S. Food and Drug Administration has granted the company 510(k) clearance to market the Solex(TM) heat exchange catheter. Solex is a new catheter, developed by Alsius, that advances the company's leadership in intravascular patient temperature management. Solex offers clinicians maximum heat exchange power from a standard neck insertion, while providing triple lumen central venous access.

"We are pleased to offer clinicians a new product that helps them deliver temperature management therapy across a wider variety of clinical scenarios," said Bill Worthen, president and chief executive officer of Alsius. "We are the only company offering high-powered temperature management via neck and leg access. This is Alsius' third product introduction this year and demonstrates our commitment to providing our customers innovative products that meet the evolving needs of their patients."

The introduction of Solex represents the newest addition to Alsius' family of catheters for use with the company's Thermogard XP(TM) and CoolGard 3000® Intravascular Temperature Management Systems. Solex features a proprietary, serpentine balloon design that maximizes surface area contact on a relatively short, thin catheter.

"Every patient presents a unique set of challenges, and some scenarios call for different insertion site preferences," commented Suzanne Winter, Vice President, Worldwide Sales and Marketing. "The addition of Solex further expands our broad family of heat exchange catheters, and provides our customers with more choices in treating their patients."

Earlier this year, Alsius introduced the new Quattro(TM) catheter, a four-balloon heat exchange catheter that provides increased surface area and power for situations requiring insertion in the leg.

Approximately 20,000 critically ill patients have been treated with Alsius IVTM products since they first became available and, currently, more than 675 systems are in place at approximately 330 hospitals worldwide.

Alsius IVTM(TM)

Alsius IVTM technology provides cooling and warming therapy via a computer-controlled temperature regulation system that connects to Alsius' proprietary heat exchange catheters. The catheters are inserted into veins in a patient's neck or leg, and circulate cool or warm saline through balloons that surround the catheters. This approach decreases or increases core temperature from the inside of the body out toward the exterior, allowing for significantly more rapid control of a patient's core body temperature, with greater efficiency and precision, compared to conventional external temperature management products such as cooling and warming blankets and ice packs.

Alsius' IVTM products include the CoolGard 3000, Thermogard(TM) and Thermogard XP systems, as well as a family of single-use catheters, including the Cool Line®, Icy®, Quattro, Solex and Fortius®.

About Alsius

Headquartered in Irvine, CA, Alsius Corporation develops, manufactures and sells proprietary products to precisely control patient temperature in hospital critical care settings. Controlling body temperature, through cooling and warming, is becoming the standard of care for patients in select critical conditions and those undergoing a variety of surgical procedures. Alsius markets a comprehensive suite of catheter-based Intravascular Temperature Management products that address the need for effective, accurate, easy-to-use and cost-effective control of body temperature in critical care patients. For more information, visit

Safe Harbor

This press release may contain statements regarding plans and expectations for the future that constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact are forward-looking. Such forward looking statements are based upon the current beliefs and expectations of Alsius' management, and are subject to risks and uncertainties which could cause actual results to differ materially from those described in the forward- looking statements. The information set forth herein should be read in light of such risks. Additional information concerning such risks and uncertainties are contained in Alsius' filings with the Securities and Exchange Commission, which can be accessed electronically on the Securities and Exchange Commission website at

Source: Alsius

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