Attune Medical Archives - Medical Design Sourcing

Haemonetics agrees to acquire esophagus-protecting device maker Attune Medical

A rendering of EnsoETM in use. [Image courtesy of Attune Medical]Haemonetics (NYSE: HAE) + announced today that it entered into an agreement to acquire Attune Medical.

Boston-based Haemonetics agreed to buy Attune for an upfront cash payment of $160 million. The deal also includes additional contingent consideration based on sales growth in the three years following the consummation of the acquisition. These additional payments also hinge on other certain milestones.

The companies expect to complete the deal in the first quarter of Haemonetics’ fiscal 2025, which ends July 1, 2024.

Chicago-based Attune medical develops the ensoETM proactive esophageal cooling device. The company designed ensoETM to reduce the likelihood of ablation-related esophageal injury. These injuries occur as a result of radiofrequency (RF) cardiac ablation procedures. ensoETM received FDA authorization for RF ablation in September 2023…

Study backs esophagus-protecting device from Attune Medical

A rendering of EnsoETM in use. [Image courtesy of Attune Medical]Attune Medical today announced positive data supporting the use of its ensoETM proactive esophageal cooling device.

Chicago-based Attune designed ensoETM to reduce the likelihood of ablation-related esophageal injury. These injuries occur as a result of radiofrequency (RF) cardiac ablation procedures.

ensoETM received FDA investigational device exemption (IDE) for this indication just over one year ago. The FDA granted the device de novo clearance earlier this month for use in RF ablation procedures.

The study, published in the Journal of the American College of Cardiology: Clinical Electrophysiology (JACC-EP), compared ensoETM to luminal esophageal temperature monitoring. It found a significant reduction in the rate of atrioesophageal fistulas (AEFs) during cardiac ablation of the left atrium when using ensoETM. AEF, the most severe form of esophageal injury that occurs during ablation proced…

FDA authorizes Attune Medical’s ensoETM for use in RF ablation procedures

A rendering of EnsoETM in use. [Image courtesy of Attune Medical]Attune Medical announced today that it received FDA de novo marketing authorization for its ensoETM device in ablation procedures.

Chicago-based Attune designed ensoETM to reduce the likelihood of ablation-related esophageal injury. These injuries occur as a result of radiofrequency (RF) cardiac ablation procedures. ensoETM received FDA investigational device exemption (IDE) for this indication just over one year ago.

The FDA nod came on the back of pre-clinical studies, computer models, three randomized controlled studies and data from tens of thousands of patients treated in real-world settings. Studies demonstrated up to an 83% reduction in esophageal injuries. Additionally, ensoETM reduced the risk of atrioesophageal fistula (AEF), a complication of ablation procedures.

De Novo authorization expands ensoETM’s indications for use to reduce the likelihood of esophageal injury in these …

Attune Medical wins FDA IDE nod to evaluate ensoETM in radiofrequency ablation procedures

[Image from Attune Medical]Attune Medical announced today that the FDA granted investigational device exemption (IDE) to study the company’s ensoETM.

Chicago-based Attune designed ensoETM to reduce esophageal thermal injury during cardiac radiofrequency (RF) ablation procedures. The IMPACT II study is underway in Europe and already enrolled nearly 20 patients.

Attune said in a news release that the single-use thermal regulating device is placed in the esophagus and connected to an external heat exchange unit. This creates a closed-loop system for heat transfer to increase or decrease patient temperature. Placement in the esophagus allows for highly efficient heat transfer due to proximity to blood flow from the heart and vessels.

The company said ensoETM’s internal placement doesn’t impede patient access during surgery. It also allows for gastric decompression and the administration of fluids and medications. Attune designed it to simplif…