CHICAGO--(BUSINESS WIRE)--Medical device firm Advanced Cooling Therapy (ACT) has expanded its team and achieved several strategic milestones in the commercial launch of its first product, the Esophageal Cooling Device (ECD).
Within less than 90 days of obtaining its de novo clearance from the FDA and manufacturing labeled product, the company has already had its first US sales of the ECD, along with first human use in the country. A total of four clinical papers have now been published globally on the efficacy of the device.
To support the strong demand for the ECD, the company promoted Robin Drassler to Vice President of North American Sales; hired Maria Gray MA, RN, as Director for Clinical Services; and added key sales managers to accommodate growth both in the US and globally, including:
- Alan Elphick
- Ruben Trevino, Ret. USAF, RN
- Bill Benson
- Dalton Akkerman
The ECD is the only temperature modulation device available today that is approved to use the esophageal environment for whole-body temperature modulation, including both cooling and warming. It’s designed to modulate and control patient temperature when clinically indicated through a single use, fully-enclosed triple lumen system that is inserted into the esophagus. Two lumens attach to existing temperature modulation equipment while a third lumen simultaneously allows gastric decompression and drainage. The ECD can be rapidly inserted by most trained health care professionals, in similar fashion to a standard gastric tube, and can be used to control patient temperature in the operating room, recovery room, emergency room, or ICU. It received FDA de novo clearance in June of 2015, its CE Mark in Europe in 2014, and is licensed for sale in Canada and Australia.
"ACT pioneered the field of core temperature management using the esophageal space. This novel approach offers clinicians the easiest method possible to quickly and safely control patient temperature, which is crucial in a wide range of clinical and surgical conditions. The market reception we’re experiencing is stronger than anything I’ve seen in 30 years of medical device commercialization, and I look forward to aggressively growing adoption of the ECD to enhance patient care in the ER, OR and ICU settings across the US and beyond,” commented Drassler.
Advanced Cooling Therapy’s technology platform provides a novel method to control patient temperature where clinically indicated using the esophageal environment.