Alsius Corp. out of Irvine, California, maker of intravascular heating/cooling systems powered by the company’s proprietary Intravascular Temperature Management (IVTM™) technology, has received 510(k) FDA clearance to market the first heat exchange catheter designed for jugular insertion. The catheter is indicated for temperature management of cardiac and neurosurgical procedures, and for patients in critical care units. We spoke to a company rep over the phone, who has informed us that the catheter is designed to be placed via the Seldinger technique, and, once placed and connected to an external heating/cooling unit, will expand inside the vein, revealing the serpentine balloon, perfused with normal saline and designed to maximize surface area contact with blood. So, prior to insertion, the catheter is smooth and lean, just like other central line catheters. The company has previously been designing its catheters for femoral placement, as illustrated above. The new catheter is shown below.
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(R) 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.”
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.
Press release: Alsius Corporation Receives 510(K) Market Clearance for Solex(TM) Catheter
Product page: Intravascular Temperature Management
