Attune Medical, Heart Rhythm Clinical Research Solutions Evaluating ensoETM Device

Attune Medical and Heart Rhythm Clinical Research Solutions (HRCRS) are partnering to evaluate Attune’s ensoETM thermal regulating device through the HRCRS Real World Evidence (RWE) consortium. HRCRS will conduct a multi-center observational study through the RWE network of high-volume cardiac electrophysiology centers to collect data on the ensoETM’s effect on throughput and patient outcomes.
 
The RWE consortium consists of approximately 50 U.S. high-volume electrophysiology centers that perform procedures such as cardiac radiofrequency ablation for the treatment of atrial fibrillation. Participating members will deploy the use of the ensoETM and collect and report data back to HRCRS for the clinical study.

“There’s enormous potential for esophageal temperature management with ensoETM to become a best practice in our industry,” HRCRS President Jose Osorio, M.D., an electrophysiologist said. “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.”

The U.S. Food and Drug Administration (FDA) has granted Attune an Investigational Device Exemption (IDE) to evaluate the company’s ensoETM in reducing esophageal thermal injury during cardiac radiofrequency ablation procedures. Several published studies have examined the use of ensoETM for this purpose, including the IMPACT single-center study and the pilot eCOOL-AF study. Most recently, a large multi-center review of more than 25,000 patients was completed.  
 
“As a current user of ensoETM, and as a member of the HRCRS RWE consortium, I am excited to support further adoption of this technology,” stated Mark Metzl, M.D., FHRS, section chief, Cardiac Electrophysiology, with NorthShore University Health System. “Our experience with ensoETM has been remarkable; published studies from our system have shown improved patient outcomes and greater procedural efficiency.” 
 
“It’s an honor to be working with the HRCRS network to collect data on the use of ensoETM,” Attune Medical CEO Jay Istvan said. “HRCRS has a long-standing commitment to advancing best practices in the field, and we are excited to get started.”
 
Attune Medical’s ensoETM is a single-use thermal regulating device placed in the esophagus (similar to a standard orogastric tube) and connected to an external heat exchange unit, creating a closed-loop system for heat transfer to increase or decrease patient temperature. Its placement in the esophagus, with proximity to blood flow from the heart and great vessels, allows highly efficient heat transfer. Unlike surface warming devices, ensoETM‘s internal placement doesn‘t impede patient access during surgery and allows gastric decompression and administration of fluids and medications.
 
Attune Medical’s medical device technology simplifies access to the patient’s core to efficiently control temperature and is the only device FDA-cleared for use in the esophagus for patient temperature management. The ensoETM device is used in critical care units, operating rooms, and emergency departments for the intentional modulation of patient core temperature and can be rapidly placed by most trained healthcare professionals.

Heart Rhythm Clinical Research Solutions is a contract research organization specializing in connecting industry clients to the right cardiac electrophysiologists and infrastructural support to conduct the most productive, efficient, and cost-effective research possible. Through strategic relationships with the organizations where  network physicians practice, HRCRS streamlines the contracting, initiation, site management and data collection efforts.
 
The ensoETM has been cleared by the FDA to control patient temperature. The ensoETM has NOT been approved or cleared by the FDA to reduce thermal injury to the esophagus during radiofrequency cardiac ablation procedures.