Gentherm Medical Launches ASTOPAD™ Patient Warming System

Rhea-AI Summary

Gentherm (NASDAQ: THRM) has received FDA 510(k) clearance for its ASTOPAD Patient Warming System, designed to prevent and treat hypothermia during surgical procedures. This system, which has been used internationally since 1989, features a silent electronic controller and proprietary warming blankets with precise temperature settings ranging from 32°C to 39°C. The innovative carbon fiber heating technology ensures enhanced patient safety and reliability, making it suitable for hospital environments. The ASTOPAD system meets all relevant medical safety standards.

Positive

• Receiving FDA 510(k) clearance for the ASTOPAD Patient Warming System.
• Proven technology in use outside the U.S. since 1989 enhances credibility.
• Advanced carbon fiber heating technology improves patient safety and comfort.

Negative

• None.

NORTHVILLE, Mich., Oct. 15, 2020 (GLOBE NEWSWIRE) -- Gentherm (NASDAQ: THRM), 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 ASTOPAD^TM 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.

Investor Contact
Yijing Brentano, Gentherm
investors@gentherm.com 
248.308.1702

Media Contacts
Melissa Fischer, Gentherm
media@gentherm.com 
248.289.9702

About Gentherm
Gentherm (NASDAQ:THRM) is a global developer and marketer of innovative thermal management technologies for a broad range of heating and cooling and temperature control applications. Automotive products include variable temperature Climate Control Seats, heated automotive interior systems (including heated seats, steering wheels, armrests and other components), battery thermal management systems, cable systems and other electronic devices. Medical products include patient temperature management systems. The Company is also developing a number of new technologies and products that will help enable improvements to existing products and to create new product applications for existing and new markets. Gentherm has over 11,000 employees in facilities in the United States, Germany, Canada, China, Hungary, Japan, South Korea, North Macedonia, Malta, Mexico, United Kingdom, Ukraine, and Vietnam.  For more information, go to www.gentherm.com.

FAQ

What is the ASTOPAD Patient Warming System by Gentherm?

The ASTOPAD Patient Warming System is a device designed to prevent and treat hypothermia in patients during surgical procedures, featuring a silent electronic controller and proprietary warming blankets.

When did Gentherm receive FDA clearance for the ASTOPAD system?

Gentherm received FDA 510(k) clearance for the ASTOPAD Patient Warming System on October 15, 2020.

What temperature range can the ASTOPAD system achieve?

The ASTOPAD system allows temperature settings to range from 32°C to 39°C, adjustable in 0.5°C increments.

How long has the ASTOPAD system been used in hospitals outside the U.S.?

The ASTOPAD system has been utilized in hospitals outside the U.S. since 1989.

What technology does the ASTOPAD Patient Warming System use?

The ASTOPAD system uses Gentherm's proprietary carbon fiber heating technology, which has been proven for safety and reliability in various applications.