Attune Medical has entered into a partnership with Heart Rhythm Clinical Research Solutions (HRCRS) to evaluate the former’s ensoETM thermal regulating device via the HRCRS Real World Evidence (RWE) consortium.
HRCRS will undertake a multi-centre observational study using the RWE network of high-volume cardiac electrophysiology centres.
The study intends to collect data regarding the effects of ensoETM on throughput and patient outcomes.
According to Attune Medical, its single-use thermal regulating device is connected to an external heat exchange unit and placed inside the oesophagus.
The device generates a closed-loop system for heat transfer to increase or reduce the temperature of patients.
The RWE consortium is made up of about 50 high-volume electrophysiology centres in the US that treat atrial fibrillation using techniques like cardiac radiofrequency ablation.
The thermal regulating device will be used by participating members to collect and report data back to HRCRS for the observational study.
HRCRS is a contract research organisation (CRO) with a focus on connecting industry clients to suitable infrastructural support and cardiac electrophysiologists. It helps them conduct research in the most productive, efficient, and cost-effective way.
HRCRS president and electrophysiologist Jose Osorio said: “There’s enormous potential for oesophageal temperature management with ensoETM to become a best practice in our industry.
“By leveraging the talent and expertise of our network members to further evaluate the ensoETM in real-time practice, we look forward to moving the use of this promising technology forward.”
In September last year, Attune received investigational device exemption (IDE) from the US Food and Drug Administration (FDA) to evaluate ensoETM in the reduction of oesophageal thermal injury during cardiac radiofrequency ablation procedures.
The IMPACT single-centre trial and the pilot eCOOL-AF study are two published studies that looked at the usage of ensoETM for this objective. Recently, a multi-centre review of more than 25,000 patients was completed.
According to Attune Medical, the thermal regulating device is the only FDA-cleared device for use in the oesophagus to manage the patient temperature.
It is designed for use in critical care units, operating rooms, and emergency departments.
