Medtronic, the global leader in medical technology, today announced new clinical data from the NAVABLATE study, which highlights the much anticipated safety and performance results on microwave ablation used bronchoscopically with the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology in conjunction with the Medtronic electromagnetic navigation bronchoscopy system. Results were reported as a late-breaking presentation at the virtual European Respiratory Society International Congress 2021, September 5, 2021.
“Patients with malignant lesions in the lung often have limited therapy options due to lesion locations, comorbidities, and treatment side effects,” said Kelvin Lau, M.A., DPhil, FRCS(CTh), a consultant thoracic surgeon at St. Bartholomew’s Hospital, London, and a principal investigator for the NAVABLATE study. “The results from the NAVABLATE study explore the potential benefit of a more individualized treatment for patients and offer a new option for surgeons and physicians to provide a minimally invasive, localized treatment of malignant lesions in the lung.”
NAVABLATE is a prospective, multi-center study that enrolled 30 subjects in the United Kingdom and Hong Kong to characterize the safety and performance of the CE Marked Emprint Ablation Catheter Kit. All patients underwent a bronchoscopic ablation procedure using the Emprint Ablation Catheter Kit and were followed for one month post procedure.
“Despite advances in treatment that can extend survival, the challenges of long-term management of tumors in the lung have been a significant barrier to improving outcomes, quality of life, and extended time with loved ones,” said Emily Elswick, vice president and general manager, Lung Health & Visualization, within the Surgical Innovations business, which is part of the Medical Surgical Portfolio at Medtronic. “Medtronic continues to take a broad transformative approach to the care continuum for the treatment of lung disease to improve diagnostics, optimize therapy and accelerate recovery.”
Results of the NAVABLATE study demonstrated bronchoscopic microwave ablation is an option for primary and oligometastatic malignant lung nodules £30mm in patients who decline or are not candidates for both surgery and stereotactic body radiation therapy (SBRT). Ablation using the Emprint Ablation Catheter Kit achieved 100% technical success (nodule reached and ablated in accordance with the study protocol) in all 30 subjects immediately post-procedure. One-month imaging showed satisfactory ablation of the nodule in 100% of subjects. The composite rate of adverse events related to the Emprint Ablation Catheter Kit was 3.3% (one subject with mild hemoptysis). There were no deaths or pneumothoraces.
The Emprint Ablation Catheter Kit is in development and recently received Breakthrough Device Designation status from the U.S. Food and Drug Administration (FDA) in April 2021. This device is not approved or cleared by FDA and is not available for sale in the U.S. The catheter is intended to be used in conjunction with the Emprint™ microwave generator and Medtronic electromagnetic navigation bronchoscopy system to provide a highly localized treatment of malignant lesions in the lung, and it can be used together with standard of care therapy when indicated. Medtronic will continue to study the safety and efficacy of the Emprint ablation catheter kit under an upcoming FDA investigational device exemption (IDE) study, with the intent to submit for device approval or clearance at a future date.
Source: Medtronic plc.