Recently released clinical data from the NAVABLATE study has shown that microwave ablation used bronchoscopically—with the Emprint Ablation Catheter Kit with Thermosphere Technology (Medtronic) in conjunction with the firm’s electromagnetic navigation bronchoscopy system—is an option for primary and oligometastatic malignant lung nodules in patients who decline or are not candidates for both surgery and stereotactic body radiation therapy (SBRT).
highlighted the safety and performance of microwave ablation used bronchoscopically with the Emprint Ablation Catheter Kit with Thermosphere Technology (Medtronic) in conjunction with the firm’s electromagnetic navigation bronchoscopy system.
The findings were released at a late-breaking presentation at the European Respiratory Society International Congress (September 5, 2021; virtual).
Kelvin Lau, a consultant thoracic surgeon at St. Bartholomew’s Hospital (London, UK) and a principal investigator for the NAVABLATE study, said: “Patients with malignant lesions in the lung often have limited therapy options due to lesion locations, comorbidities, and treatment side effects.
“The results from the NAVABLATE study explore the potential benefit of a more individualised treatment for patients and offer a new option for surgeons and physicians to provide a minimally invasive, localised treatment of malignant lesions in the lung.”
NAVABLATE is a prospective, multi-centre study that enrolled 30 subjects in the UK and Hong Kong to characterise 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.
Ablation using the Emprint Ablation Catheter Kit achieved 100% technical success 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 haemoptysis). There were no deaths or pneumothoraces.
Emily Elswick, vice president and general manager of lung health and visualisation at Medtronic, added: “Despite advances in treatment that can extend survival, the challenges of long-term management of tumours in the lung have been a significant barrier to improving outcomes, quality of life, and extended time with loved ones.
“Medtronic continues to take a broad transformative approach to the care continuum for the treatment of lung disease to improve diagnostics, optimise therapy and accelerate recovery.”
The Emprint Ablation Catheter Kit received Breakthrough Device Designation status from the US 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 US.
Medtronic say they 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.