MCRA, LLC, a leading medical device focused regulatory advisory firm and clinical research organization (CRO) integrating U.S. and International Regulatory Affairs, Clinical Trial Operations, Reimbursement and Market Access, Healthcare Compliance, Cybersecurity, Quality Assurance, and Japan Distribution Logistics (DMAH) is pleased to announce its role in assisting Attune Medical with its De Novo marketing authorization from the US Food and Drug Administration (FDA) for the ensoETM™ device to reduce the likelihood of ablation-related esophageal injury resulting from radiofrequency cardiac ablation procedures.
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. This new marketing authorization establishes a new Product Code, expanding the classification of ensoETM as a temperature regulation device for esophageal protection during cardiac ablation procedures. Attune Medical is the pioneer of using the esophageal space to manage temperature and received its first De Novo authorization in 2015. Over 50,000 patients have been treated with the ensoETM to date in critical care units, emergency rooms, operating rooms, and electrophysiology labs.
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MCRA’s Cardiovascular Regulatory experts assisted Attune Medical through regulatory strategy, pre-submission and De Novo submission to the US FDA utilizing the totality of clinical data available. This included strategic planning, guidance, and recommendations on inquiries from the FDA for the submission. Together, Attune Medical and MCRA were able to present FDA with a sound regulatory approach, clear framing of complex datasets and a compelling benefit-risk assessment. Over the past year, the partnership began in strategic regulatory support and developed into a dynamic collaboration committed to expanded market authorization.
Erik Kulstad, MD, MS, Co-founder & CMO of Attune Medical said, “The MCRA team includes many who came from leadership positions within FDA, and who bring valuable insight and astute recommendations based on their deep understanding of the current regulatory framework.”
Fernando Aguel, Vice President of Heart Failure and Circulatory Support at MCRA, stated, “Attune Medical’s team put their trust in collaborating with the Cardiovascular team at MCRA to ensure the most rigorous and analytic approach to requesting De Novo marketing authorization from the US FDA. Our team worked diligently to strategize accordingly, bringing in our decades of FDA expertise and industry knowledge to help achieve a positive result for our client. We are thrilled to have been a part of Attune Medical’s label expansion for the ensoETM device.”
Glenn Stiegman, Senior Vice President of Clinical and Regulatory Affairs said, “This is such an exciting product that can really make an impact on a lot of patients by altering the clinical practice of how RF cardiac ablations are performed. It’s an honor for MCRA to be a part of ensoETM and its success. Attune’s success is a testament to the working relationship and culture we strive to create at MCRA. MCRA’s regulatory team believes in creating a trusting partnership with its clients that strive for one goal, getting their product into the hands of physicians to help patients. This inherent trust allows us to work hard to help our clients, like Attune Medical, receive the necessary clearance to bring this potentially life-saving device to a larger market quickly and safely. We thank Attune Medical for entrusting us with this critical project for the ensoETM device.”
Andrew J. Kaplan, MD, FACC, FHRS, Director of Electrophysiology, Phoenix Heart, PLLC in Arizona, and Reserve Corps Cardiology Specialty Leader, US Navy, added, “I’m thrilled to see this label expansion for the ensoETM. My practice has been using this device for more than two years, and we’ve found improvements in procedural efficiency, lab throughput, and fluoroscopy requirements, beyond the substantial safety benefits we recently published. This latest marketing authorization is a significant step forward for patients.”