Attune Medical said today that it won an expanded indication from the FDA for its Enso esophageal temperature management device.
Formerly known as Advanced Cooling Therapy, Chicago-based Attune said the new indication covers extended duration of use for up to 72 hours.
The triple lumen system is designed to be inserted into the esophagus, with two lumens attached to existing temperature modulation equipment and third providing gastric decompression and drainage. The device first won de novo clearance from the federal safety watchdog in June 2015.
“As awareness of the importance of effective targeted temperature management increases, the EnsoETM delivers a simple and innovative solution for a complex therapy. Recent studies have shown the EnsoETM to have substantial benefits, including temperature maintenance capabilities that exceed those of competitors, and significant cost savings; this extended dwell time is a strong step forward in patient care that will help clinicians in the US in a multitude of clinical settings,” clinical services VP Maria Gray said in prepared remarks.