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 U.S. 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 in the U.S. and globally.
The ECD is a temperature modulation device 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. 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. •