A Digital Publication for the Practicing Medical Specialist, Industry Executive & Investor

No Carolina / New York

FDA OK’s ensoETM for Use in Cardiac Ablations to Reduce Risk of Esophageal Injury

Attune Medical has been granted De Novo marketing authorization from the US Food and Drug Administration (FDA) for its ensoETM device to reduce the likelihood of ablation-related esophageal injury resulting from radiofrequency cardiac ablation procedures.

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.  Published studies that have examined the use of ensoETM for this purpose include the pilot eCOOL-AF study, the IMPACT study and a large multi-center analysis of over 25,000 patients (in press at the Journal of the American College of Cardiology: Clinical Electrophysiology). These studies have found up to an 83 percent reduction in esophageal injuries, and a significant reduction in risk of atrioesophageal fistula (AEF), one of the most dreaded complications of ablation procedures.

Cardiac ablation utilizing radiofrequency energy is used to restore normal heart rhythm in patients with atrial fibrillation by disrupting faulty electrical pathways that interfere with normal rhythm. It is the most common type of cardiac ablation procedure, with over 300,000 per year performed in the US alone.

Commonly available technologies to mitigate serious complications have not been successful in reducing the risk of catastrophic esophageal injuries in over 20 years of use.  This De Novo marketing authorization expands the ensoETM’s indications for use to reduce the likelihood of esophageal injury resulting from radiofrequency cardiac ablation procedures. The ensoETM is the pioneer of using the esophageal space to manage temperature and has been cleared for use for the control of patient temperature since 2015.  Over 50,000 patients have been treated with the ensoETM to date in critical care units, emergency rooms, operating rooms, and electrophysiology labs.

“Historically, there have been no proven strategies to prevent esophageal injury during ablation procedures, and injury rates have not declined despite the use of temperature probes,” commented Jason Zagrodzky, MD, FHRS, Electrophysiologist at Texas Cardiac Arrhythmia in Austin, Texas.  “This De Novo authorization gives electrophysiologists a solution to proactively cool the esophageal wall during ablation procedures and is a great leap forward in best practice standards and patient care. We have found a 35 percent reduction in fluoroscopy requirements with cooling, as well as a reduced staff workload which results in significant cost savings to hospital systems.”

“Our lab has published studies showing a 30 percent reduction in procedure time and a 14 percent improvement in long-term efficacy when using ensoETM,” noted Mark Metzl, MD, FHRS, Section Chief, Cardiac Electrophysiology at NorthShore University Health System.  “These findings have in turn been shown to result in a quicker return home for patients and a cost savings of up to $2,135 per procedure.”

“Over the last 20 years, significant resources have been committed to mitigating serious esophageal complications, with no meaningful results. This De Novo marketing authorization opens the door to a new standard.  Studies have shown improved safety and efficacy for patients while allowing improved efficiency for physicians and greater cost savings for the hospitals in which they operate,” commented Jay Istvan, Attune Medical’s CEO.

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.

Attune Medical’s novel medical device technology pioneered the practice of using the esophageal space to proactively manage patient temperature and to reduce the likelihood of esophageal injury resulting from radiofrequency cardiac ablation procedures.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

OTHER NEWS

Simpson Interventions Receives FDA Breakthrough Device Designation for Acolyte™ Image Guided Crossing and Re-Entry Catheter System

Simpson Interventions is committed to collaborating closely with the FDA and other stakeholders to advance the development and regulatory review of the Acolyte Image Guided Crossing and Re-Entry Catheter System. The company looks forward to bringing this revolutionary technology to clinicians, and patients in need.

Transforming Tricuspid Valve Care: FDA Gives Green Light to Abbott’s TriClip™

"The U.S. approval of TriClip is a significant advancement for people suffering from tricuspid regurgitation, a heart condition that negatively impacts their quality of life and puts them at grave risk of serious health issues," said Paul Sorajja, M.D., the Roger L. and Lynn C. Headrick Family Chair of the Valve Science Center for the Minneapolis Heart Institute Foundation and director of the Center for Valve and Structural Heart Disease for the Minneapolis Heart Institute at Abbott Northwestern Hospital and co-principal investigator of the TRILUMINATE™ Pivotal trial. "With TriClip, physicians can offer patients a therapy option backed by excellent safety and effectiveness to help restore tricuspid native valve performance without subjecting them to high-risk open-heart surgery that may not be feasible for individuals with TR who are generally older and sicker."

HeadaTerm 2: The Most Affordable FDA Cleared Innovative OTC Anti-Migraine Device

This make it one of the only wearable OTC anti-migraine device that is available without a prescription in the U.S.

Cutting-Edge Nanodrop Device Granted FDA Clearance for At-Home Blood Tests

NanoDrop has received clearance in the United States as the inaugural blood-lancing device available for over-the-counter use on the upper arm. This development is poised to revolutionize the consumer testing market and decentralized clinical trials within the realm of at-home healthcare.

By using this website you agree to accept Medical Device News Magazine Privacy Policy