Medtronic (NYSE:MDT) announced today that it received FDA breakthrough device designation for its Emprint ablation catheter kit.
Fridley, Minn.-based Medtronic’s catheter is designed to be used in conjunction with the Emprint microwave generator and the Medtronic lung navigation platform to offer a minimally invasive, localized treatment of malignant lesions in the lung, according to a news release. It can also be used together with the standard of care therapy when indicated.
Less invasive local treatment modalities like the Emprint ablation catheter kit offer a survival benefit when combined with local therapy in treating lung malignancies, Medtronic said.
Emprint uses an endoluminal approach and will be studied with the Medtronic lung navigation system to offer the accurate delivery of microwave energy to the targeted lung lesion(s). The kit has garnered CE mark approval but is not yet available in the U.S.
“At Medtronic, we strive to transform outcomes by taking bold actions to ensure that patients with tumors in the lung receive care sooner, less invasively, and more effectively,” Medtronic VP & GM of lung health & visualization Emily Elswick said in the release. “Breakthrough designation from the FDA is just the first step in realizing our broader commitment to providing less invasive treatment options to patients with lung disease.”
