October 12, 2023MCRA Assists Attune Medical on FDA De Novo Marketing Authorization for ensoETM™ Esophageal Thermal Regulating Device
Attune Medical’s ensoETM is a single use thermal regulating device that is placed in the esophagus (similar to a standard orogastric tube) and connected to an external heat exchange unit, creating a closed-loop system for proactive controlled temperature management.
SEPTEMBER 26, 2023Study Finds Significant Reduction in Esophageal Injury Rate When Using ensoETM™ During Cardiac Radiofrequency Ablation Procedures
The study, Atrioesophageal Fistula Rates Before and After Adoption of Active Esophageal Cooling During Atrial Fibrillation Ablation, set out to compare the rate of AEFs before and after the adoption of proactive esophageal cooling. [Business Wire]
SEPTEMBER 14, 2023
The FDA based its decision on pre-clinical studies, computer models, three randomized controlled studies, and data on tens of thousands of patients treated in real-world uses. [Business Wire]
AUGUST 30, 2023Attune Medical Announces Non-Exclusive Distribution Agreement with Gentherm to Provide Blanketrol® III Heat Exchangers to ensoETM Users
Adopters of Attune’s ensoETM thermal regulating device will be provided the opportunity to use a bundled disposable purchase option to acquire Gentherm’s Blanketrol III directly from Attune.
MAY 09, 2023Attune Medical to Attend Heart Rhythm Society May 19 to 21 in New Orleans
The company will show the latest proactive esophageal cooling technology at Booth 521 and host an evening meet-and-greet. [Business Wire]
APRIL 11, 2023Attune Medical and Heart Rhythm Clinical Research Solutions (HRCRS) Collaborate With Real World Evidence Consortium Members to Evaluate ensoETM™ in High Volume Centers
The RWE consortium consists of approximately 50 US high-volume electrophysiology centers that perform procedures such as cardiac radiofrequency ablation for the treatment of atrial fibrillation. [HMP Global]
September 08, 2022
The US Food and Drug Administration (FDA) has granted an Investigational Device Exemption (IDE) to Attune Medical to evaluate the company’s ensoETM in the reduction of esophageal thermal injury during cardiac radiofrequency ablation procedures. [Business Wire]