Advanced Cooling Therapy said today it won FDA 510(k) clearance for its Esophageal Cooling Device with an integrated Altrix precision temperature management system from Stryker (NYSE:SYK).
The Chicago-based company said the triple lumen system is designed to be inserted into the esophagus, with 2 lumens attached to existing temperature modulation equipment while a 3rd lumen simultaneously allows for gastric decompression and drainage.
ACT said that the system can be rapidly inserted in a similar fashion to a standard gastric tube, and can be used to control patient temperature in most hospital settings.
“The ECD is being adopted across the US, and globally, in an increasing number of hospitals to warm or cool patients when clinically indicated, and this clearance for use with the Altrix precision temperature management system will further support that growth. The ECD is easy to use, doesn’t require additional capital purchase, and is compatible with the majority of available control units. We are addressing a significant demand in emergency departments, intensive care units and operating rooms for a wide range of temperature management needs,” NA sales VP Robin Drassler said in a press release.
In January, ACT won CE Mark approval for the next-gen version of the ECD with Stryker’s Altrix precision temperature management system.
Last May, ACT said it won expanded CE Mark approval in the European Union for the base Esophageal Cooling Device, now cleared to be used for up to 120 hours in patients needing warming or cooling.
