Medtronic Receives FDA Clearance, Announces First Uses of New Oxygenation System

Medtronic, Inc.

today announced U.S. Food and Drug Administration (FDA) 510(k) clearance and the first U.S. clinical uses of its new Affinity Fusion^® oxygenation system. This system, which is designed to serve as a patient's lungs by oxygenating and removing carbon dioxide from blood during various open-heart surgical procedures, incorporates numerous innovations for patient safety and ease of use. Notably, system enhancements are designed to prevent and remove air bubbles that can enter the blood during the procedure, which may potentially reduce the risk of stroke. The Affinity Fusion oxygenation system's new design enhancements include: o A proprietary fiber winding process with an interlaced pattern that efficiently filters the blood and removes particles and air while at the same time oxygenating the blood; o Smooth tubular pathways for blood to pass through and a first-of-its-kind curved venous inlet tube, both of which can reduce blood turbulence during the surgical procedure; o Enhanced setup and customization capabilities, including a new oxygenator system holder, which gives perfusionists improved flexibility and ease of use in various operating rooms, including those with limited space.