REGULATORY NEWS

Alsius nets clearance for heat exchange catheter for intravascular patients

Written by Editorial Staff   
August 27, 2008
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The FDA has granted Alsius 510(k) clearance to market its Solex heat exchange catheter for intravascular patient temperature management.

Solex offers clinicians heat exchange power from a standard neck insertion, while providing triple lumen central venous access, according to the Irvine, Calif.-based company.

Alsius said its introduction of Solex represents the newest addition to Alsius’ family of catheters for use with the company's Thermogard XP and CoolGard 3000 intravascular temperature management systems. The company said its Solex features a proprietary, serpentine balloon design that uses surface area contact on a short, thin catheter.