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April 28, 2021

FDA grants breakthrough status to Medtronic’s ablation catheter kit

The US Food and Drug Administration (FDA) has granted breakthrough device designation status to Medtronic’s investigational device, the Emprint ablation catheter kit.

The US Food and Drug Administration (FDA) has granted breakthrough device designation status to Medtronic’s investigational device, the Emprint ablation catheter kit.

To be used along with the Emprint microwave generator and Medtronic lung navigation platform, the catheter can offer less invasive, localised treatment of malignant lesions in the lung.

The lung navigation platform aids in precise and correct ablation catheter placement within the target lesion, which is vital to the success of less invasive procedures.

The CE-marked Emprint ablation catheter kit can also be used in combination with standard of care therapy when indicated.

It is being analysed in the NAVABLATE study, which concluded enrolment of 30 participants in Europe and Hong Kong last year.

Medtronic lung health and visualisation vice-president and general manager Emily Elswick said: “At Medtronic, we strive to transform outcomes by taking bold actions to ensure that patients with tumours in the lung receive care sooner, less invasively and more effectively.

“Breakthrough designation from the FDA is just the first step in realising our broader commitment to providing less invasive treatment options to patients with lung disease.”

Existing clinical guidelines support a multimodal method for malignant lung lesion management, which is based on the stage of the tumour and can include surgery, radiotherapy and/or systemic drug therapy.

Medtronic noted that as patients with lung malignancies have demonstrated survival benefit from combining systemic and local therapy, minimally invasive local treatment modalities like the Emprint ablation catheter kit were developed.

Using an endoluminal approach and the Medtronic lung navigation system, the catheter kit will be assessed to aid in the precise delivery of microwave energy to targeted lung lesions.

Principal investigator of the NAVABLATE study Kelvin Lau said: “This new technology has allowed me to personalise treatment of lung lesions for each patient, particularly lesions that may be challenging to manage.”

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