August 26, 2008 - Alsius Corp., manufacturer of intravascular temperature management (IVTM) therapies, today said the FDA granted 510(k) clearance to market its Solex heat exchange catheter.
Solex is a new catheter offering maximum heat exchange power from a standard neck insertion, while providing triple lumen central venous access, the company said.
The Solex is the newest addition to Alsius' family of catheters for use with the company's Thermogard XP 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.
Earlier this year, Alsius introduced the new Quattro 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, the company said.