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affinity cp centrifugal blood pump with balance biosurface
Medtronic
Summary: The Affinity CP Centrifugal Blood Pump is a medical device used in extracorporeal circulation during cardiac surgery. It is primarily utilized by cardiac surgeons and perfusionists to support blood flow.
FDA Clearance Information
Pathway
510K
Number
K111657 ↗
Decision Date
June 23, 2011
Product Code
KFM
Device Class
Class 2
Evidence
0 studies
The Affinity CP Centrifugal Blood Pump by Medtronic was cleared through the FDA 510(k) pathway on June 23, 2011. It is a Class 2 device under product code KFM.
What It Is
The Affinity CP Centrifugal Blood Pump is a device designed to support extracorporeal circulation by pumping blood outside the body during cardiac surgery. It utilizes centrifugal force to move blood, minimizing shear stress and reducing the risk of hemolysis. The Balance Biosurface technology is incorporated to enhance biocompatibility and reduce inflammatory responses.
Clinical Applications
This device is commonly used in cardiac surgery settings, particularly during procedures that require cardiopulmonary bypass. It is utilized by cardiac surgeons and perfusionists to maintain blood circulation and oxygenation when the heart is stopped. It is suitable for adult and pediatric patients undergoing cardiac procedures.
Indications for Use
The Affinity CP Centrifugal Blood Pump is indicated for use in patients requiring extracorporeal circulation during cardiac surgery. It is specifically designed to support blood flow and oxygenation when the heart is not functioning normally.
Practical Considerations
The device is compatible with standard extracorporeal circuits and is available in various sizes to accommodate different patient needs. Clinicians should be familiar with the setup and operation of centrifugal pumps and ensure compatibility with other components of the extracorporeal circuit.
Related Literature
The linked study compared the hemolysis effects of a magnetic levitation pump and a constrained vortex pump during minimally invasive extracorporeal circulation. It found that elevated plasma free hemoglobin, which can lead to multi-organ injury, was reduced with minimally invasive technologies. However, the study was a pilot and may have limitations in sample size and generalizability.
Frequently Asked Questions
What is the Affinity CP Centrifugal Blood Pump used for?
It is used for extracorporeal circulation during cardiac surgery to support blood flow and oxygenation.
What specialties typically use this device?
Cardiac surgeons and perfusionists in cardiac surgery settings.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring extracorporeal circulation during cardiac surgery.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.