Medtronic received FDA clearance for its Affinity Fusion blood oxygenation/CO2 removal system for open heart surgeries. The new system was designed with particular engineering attention paid to reducing bubble formation and so preventing air embolisms.
The Affinity Fusion was approved in Europe in September of last year and has already been used successfully in the U.S. at the Cleveland Clinic.
Features in the new oxygenator:
- 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 can 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.
Flashback: Medtronic Affinity Fusion Blood Oxygenation System Cleared in Europe…
Product page: Affinity Fusion…
Press release: Medtronic Announces FDA Clearance and First Uses of New Oxygenation System for Adult Cardiac Surgery…