The ASTOPAD Patient Warming System is a proven device that has been utilised by hospitals outside the United States since 1989

FDA device

The US FDA’s Center for Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration)

Gentherm, a global market leader and developer of innovative thermal management technologies today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and has launched the ASTOPADTM Patient Warming System in the United States. The ASTOPAD system can be utilized in all surgical procedures and helps prevent and treat hypothermia in patients throughout the perioperative journey.

The ASTOPAD Patient Warming System is a proven device that has been utilized by hospitals outside the United States since 1989. The system consists of a silent electronic controller and a selection of proprietary warming blankets. The controller has two cable connections that can control two blankets simultaneously. A warming blanket can be placed over and/or under the patient, where the temperature settings of the controller range from 32°C – 39°C, and can be set individually in precise 0.5°C increments.

All ASTOPAD blankets are made of Gentherm’s proprietary carbon fiber heating technology, where each blanket is designed with eight integrated sensors enabling enhanced patient safety and precise temperature control. The heating technology has been installed in over 80 million vehicles. Its unique, grid-like design enables safety, durability and reliability.

“The launch of the ASTOPAD Patient Warming System demonstrates our deep understanding of human thermophysiology and how we are able to leverage technology from our automotive business to provide advancements in patient temperature management in our medical business,” said Phil Eyler, President and CEO of Gentherm. “Our carbon fiber heating technology was originally designed for comfort, warmth, reliability and safety in automotive passenger thermal management. This technology is ideal for the Operating Room and anywhere in a hospital when medical professionals need quiet, comfortable and reliable warming to help prevent and treat hypothermia in a surgical patient.”

The ASTOPAD system is compliant with all the latest electrical, ISO and safety standards for a medical patient warming device.

Source: Company Press Release