Celsius Control System™

Product Brochure

The Celsius Control System™ consists of a disposable endovascular heat transfer catheter, administration cassette, and a console. The distal portion of the catheter (10.7F and 14F) has a flexible, metallic temperature control element (TCE) that is cooled or warmed by sterile saline circulated within it from the Celsius Control™ Console. The administration cassette connects the catheter to the console, maintaining the sterility of the saline conduit. The TCE does not expand inside the body so the outer diameter of the TCE will remain consistent throughout the entire cooling/warming procedure unlike balloon based cooling systems which expand to outer diameters of 24F-47F during use.

The TCE has a proprietary surface of alternating helices that induces mixing and significantly enhances heat transfer directly with the blood flowing in the inferior vena cava. In addition, the use of a flexible metal heat exchanger, further optimizes heat transfer due to the high thermal conductivity of metal. The flexibility of the TCE is achieved through uniquely designed segmented bellows joints. The catheter can also be placed in an operating room or ICU setting without the need for continuous fluoroscopy.

The TCE and catheter are coated with the Applause™ heparin coating from Surmodics, Inc. The Applause coating is covalently bonded to the surface of Innercool catheters through a proprietary PhotoLink™ process. Covalent bonding insures a more durable, active heparin coating compared to the short-lived nature of ionically bound heparin coatings. The Applause coating has demonstrated that over 80% of the heparin activity remains after 28-days of saline incubation.

Accutrol™ Catheter

Innercool's Accutrol™ catheter contains an integrated temperature sensor, which can accurately determine the patientās core body temperature within 0.1°C of pulmonary artery temperature. The proprietary, novel Accutrol software control algorithm provides automated body temperature control . The Accutrol system eliminates the need to place bladder or rectal probes which can be slow to react to actual decreases in core body temperature, may be uncomfortable to the patient and time-consuming to place.

Temperature control at target temperature is very tight and the alogorythm allows for gradual rewarming times which can be programmed from 3-24 hours. The Accutrol catheter is beneficial in the critical care environment where gradual rewarming may be warranted.

Model Number French Size Catheter Length TCE Length 11-10-65-2 10.7F 65CM 23CM 11-14-65-2 14F 65CM 23CM

Standard catheter

The Standard catheter incorporates the same design features as the Accutrol catheter including performance attributes. However, an external core temperature feedback probe is required for operation.

Model Number French Size Catheter Length TCE Length 11-10-65-1 10.7F 65CM 23CM 11-14-65-1 14F 65CM 23CM

Indication Statement from U.S. FDA
The Celsius Control System is a thermal regulating system to induce, maintain and reverse mild hypothermia in neurosurgical patients in surgery and in recovery/intensive care, to achieve and/or maintain normothermia in cardiac surgery patients in surgery and in recovery/intensive care and for use in fever reduction, as an adjunct to other antipyretic therapy, in patients with cerebral infarction and intracerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated.

Warning — Fever Reduction
The safety of this device has not been demonstrated for fever reduction in patients presenting with subarachnoid hemorrhage or primary traumatic brain injury. A randomized controlled study of endovascular cooling in patients with subarachnoid hemorrhage and primary traumatic brain injury has shown increased mortality as compared to patients receiving standard of care.

How To Order

Customer Service
8:00am — 5:00pm PST/PDT

sales@INNERCOOL.com

1.866.682.COOL (1.866.682.2665)

1.858.713.9536 Fax