A company that believes the best way to manage a patient's body temperature is from the inside out rather than the outside in has just received FDA 510(k) clearance for its newest heat exchange catheter.

Alsius (Irvine, California) said its Solex heat exchange catheter is designed to offer clinicians maximum heat exchange power from a standard neck insertion, while providing triple lumen central venous access.

"Solex is a much more powerful catheter designed to be inserted in the neck," Bill Worthen, president/CEO of Alsius, told Medical Device Daily. "The catheters are kind of like the software that run off a system," he said.

Solex is the newest addition to Alsius' family of catheters for use with the company's Thermogard XP and CoolGard 3000 intravascular temperature management (IVTM) systems. The device features a serpentine balloon design that maximizes surface area contact on a relatively short, thin catheter, the company said.

"We are pleased to offer clinicians a new product that helps them deliver temperature management therapy across a wider variety of clinical scenarios," Worthen said. "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."

Alsius IVTM technology provides cooling and warming therapy via a computer-controlled temperature regulation system that connects to Alsius' 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 low-tech products such as cooling and warming blankets and ice packs.

"The medical community is rapidly and increasingly understanding the importance of temperature," Worthen told MDD.

The benefit of heating or cooling a patient from the inside out, Worthen said, is that you can get to your target temperature much more rapidly and maintain it with more precision and accuracy.

According to Alsius, roughly 20,000 critically ill patients have been treated with its IVTM products and, currently, more than 675 systems are in place at about 330 hospitals worldwide.

"Every patient presents a unique set of challenges, and some scenarios call for different insertion site preferences," said Suzanne Winter, VP of worldwide sales and marketing for the company. "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 Quattro catheter, a four-balloon heat exchange catheter that provides increased surface area and power for situations requiring insertion in the leg. The company's other single-use catheters are the Cool Line, Icy and Fortius.

Alsius launched its Thermogard XP earlier this year (Medical Device Daily, Jan. 28, 2008).

The company became the third player in the endovascular temperature control sector in 2003 when it received FDA clearance for its Cool Line catheter and CoolGard 3000 system for use as an adjunct to other fever management therapies in patients with cerebral infarction and intracerebral hemorrhage, two common forms of stroke (MDD, Aug. 25, 2003). Radiant Medical (Redwood City, California) was the first sector entrant when it received U.S. approval of its system in cardiovascular procedures in June 2002. Later, Innercool Therapies (San Diego) won 510(k) clearance for its hypothermia technology in neurosurgical applications.

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