Alsius Corporation, a medical device company headquartered in Irvine, CA, has received approval from regulatory authorities in China and Mexico to market its intravascular temperature management (IVTM) systems and catheters in those countries. Alsius IVTM provides cooling and warming therapy via a computer-controlled temperature regulation system that connects to Alsius' proprietary heat exchange catheters.
"Although we are still at the very early stages of development in Asia and Latin America, we are excited about introducing the first intravascular temperature management product in China and Mexico and hope to leverage this advantage to grow those markets. Alsius continues to make progress in growing the international market for its 'inside-out' approach to therapeutic temperature management," said Mr Bill Worthen, President and CEO of Alsius.
Alsius hired a sales manager, in 2007, to oversee growth of the Asia-Pacific region. The company currently has regulatory approval in Thailand, South Korea, Australia, Taiwan and Malaysia. Additionally, there is an application in process in Japan, and the company has initiated the regulatory approval process in several other countries.
Alsius' IVTM consists of the CoolGard 3000, Thermogard and Thermogard XP systems and a family of single-use catheters, including the Icy, Fortius and Quattro catheters. The catheters are inserted into a major vein through a patient's neck or groin, and circulate cool or warm saline in a closed-loop 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.