Medtronic Gets FDA Breakthrough Designation for Emprint Ablation Catheter Kit

By Colin Kellaher

Medtronic PLC Tuesday said the U.S. Food and Drug Administration granted breakthrough-device designation to its Emprint ablation catheter kit.

The Dublin-based medical-technology company said the device, if approved, would be used in conjunction with its Emprint microwave generator and its lung-navigation platform to provide a minimally invasive, localized treatment of malignant lesions in the lung.

The FDA's breakthrough-devices program aims to expedite the development and review of technology that offers significant advantages over existing approved products. Medtronic said that under the program, the FDA will provide priority review and interactive communication regarding clinical trial designs through to commercialization decisions.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

04-27-21 1025ET