Medtronic (NYSE:MDT) reported new clinical data from its Navablate study of bronchoscopic microwave ablation with its Emprint ablation catheter kit to treat malignant lung nodules.
“Patients with malignant lesions in the lung often have limited therapy options due to lesion locations, comorbidities and treatment side effects,” said one of the principal investigators, Kelvin Lau — consultant thoracic surgeon at St. Bartholomew’s Hospital in London — in a news release. “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.”
Surgeons in the United Kingdom and Hong Kong performed bronchoscopic ablation on 30 patients using Medtronic’s Emprint ablation catheter kit and the device maker’s electromagnetic navigation bronchoscopy system. Investigators determined that all nodules were reached and ablated immediately after the procedures, and said imaging one month later indicated satisfactory ablation in all nodules.
Medtronic reported no deaths or pneumothoraces and said the composite rate of adverse events related to the Emprint ablation catheter kit was 3.3% due to one patient with mild hemoptysis.
The Fridley, Minnesota-based medical device maker released results of the prospective study on Sept. 5 at the European Respiratory Society International Congress 2021.
The Emprint ablation catheter kit has the CE mark from European regulators and won FDA Breakthrough Device Designation status in April. Medtronic said it will keep researching the safety and efficacy of the Emprint ablation catheter kit under an upcoming FDA investigational device exemption study and intends to submit for device clearance or approval at an unspecified time.
“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,” Emily Elswick —vice president and general manager of Lung Health & Visualization in Medtronic’s Surgical Innovations business — said in the news release.