Technology Overview

The Celsius Control System™ provides physicians with a state-of-the-art, endovascular technology that can safely and rapidly lower patient body temperature, precisely maintain a chosen target temperature and rewarm patients to normothermic levels.

Medical research suggests there are a number of potential clinical applications for the Celsius Control System such as inducing mild hypothermia in surgery, stroke and heart attack or for temperature control in surgical and critical care procedures.

The Celsius Control System consists of an endovascular catheter, console and proprietary disposables. The distal portion of the catheter incorporates a flexible Temperature Control Element (TCE) that is cooled or warmed with saline solution circulated in a closed-loop manner from the console. When placed in the inferior vena cava, the TCE exchanges thermal energy directly with the blood, resulting in cooling or warming of the downstream organs and body. The Celsius Control System does not infuse fluid into the patient, nor is blood circulated outside of the body.

INNERCOOL received FDA clearance in January 2003 for the Celsius Control System to induce, maintain and reverse mild hypothermia in neurosurgical patients in surgery and recovery/intensive care. Subsequent indications for the CCS have also been obtained in fever control and cardiac surgery. The company has received the CE mark allowing the Celsius Control System to be marketed in the European Community.

Clinical experience with the Celsius Control System has shown average cool down rates of 5.0 - 6.0°C/hr, target temperature control of ±0.1°C and average rewarm rates of 2.0 - 3.0°C/hr. See our Performance Data page to view a clinical performance curve of the Celsius Control System.