Posted by Michael Wonder on 27 Apr 2021
Medtronic receives FDA breakthrough designation for the Emprint ablation catheter kit
27 April 2021 - Minimally invasive option has potential to provide long-term management of lung malignancies while protecting lung function.
Medtronic today announced it has received Breakthrough Device Designation status from the U.S. FDA for the Emprint ablation catheter kit – an investigational device not yet approved or cleared in the United States.
The catheter is intended to be used in conjunction with the Emprint microwave generator and Medtronic lung navigation platform to provide a minimally invasive, localised treatment of malignant lesions in the lung, and it can be used together with standard of care therapy when indicated.
