Medtronic announces study results in malignant lung cancer therapy at respiratory congress

MedTech News: Lung cancer patients with small nodules who cannot or will not undergo surgery or radiotherapy can be successfully treated with targeted transbronchial microwave ablation, indicate results from a UK-led trial.

Medtronic announced the new clinical data at the recent European Respiratory Society International Congress 2021 highlighting 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 in patients with malignant lung cancer.

“Patients with malignant lesions in the lung often have limited therapy options due to lesion locations, comorbidities, and treatment side effects,” said Dr Kelvin Lau, 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 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.”

Current clinical guidelines for the management of malignant lung cancer support a multimodal approach, which may include surgery, radiotherapy, and/or systemic drug therapy, depending on the tumour stage. 

NAVABLATE is a prospective, multi-centre study that enrolled 30 subjects in the United Kingdom 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.

“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,” said Emily Elswick, vice president and general manager, Lung Health & Visualisation, within the Surgical Innovations business, which is part of the Medical Surgical Portfolio at Medtronic.”

Results of the NAVABLATE study demonstrated bronchoscopic microwave ablation is an option for primary and oligometastatic malignant lung nodules of ≤ 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 haemoptysis). 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. In Australia, it is currently approved by the Therapeutic Goods Administration (TGA) for liver cancer treatment only.

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.