Medtronic received FDA clearance for its Affinity Pixie Oxygenation System, a CO2/O2 exchange device for use in cardiopulmonary bypass surgeries on neonates, infants and small children. Beside performing gas exchange duties, the Affinity Pixie warms or cools blood passing through it to a desired temperature.
The oxygenator can deliver a 2.0 L/min maximum flow rate with an initial priming of 48 mL, and the internals of the device are coated with Balance Biosurface, a hydrophilic surface that doesn’t use heparin in preventing blood clots.
Some of the device features from the product page:
Oxygenator: Medtronic proprietary graduated fiber bundle density technology and radial-radial flow path design for:
- Enhanced gas transfer
- Low blood-side pressure drop
- Decreased prime volume
- Uniform blood distribution
- Avoidance of areas of stasis
Reservoir:
- 2.0 L/min maximum flow rate
- 1200 mL volume capacity
- 20 mL minimum operating volume without vortex formation
- Non-foaming blood does not contact antifoam at typical reservoir operating levels
- Independent rotation of venous inlet and cardiotomy turret
- Vacuum assisted venous drainage-ready design
- Balance™ Biosurface
- Device and accessories do not contain DEHP
Product page: Affinity Pixie Oxygenation System
Press release: Medtronic Gains FDA Clearance for New Pediatric Oxygenation System for Neonate, Infant and Pediatric Cardiopulmonary Bypass Surgery
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