Medtronic has received the CE Mark for the Affinity Fusion, a system for oxygenating blood and removing CO2 during open heart surgeries. The company spent considerable effort designing the device to minimize the formation of air bubbles in the oxygenated blood that can lead to dangerous side effects like stroke.
Medtronic is planning on submitting papers to the FDA to seek approval for the Affinity Fusion in the U.S.
New features from the announcement:
- 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;
- Smooth tubular pathways for blood to pass through and a first-of-its-kind curved venous inlet tube, both of which reduce blood turbulence during the surgical procedure;
- 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.