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affinity cp centrifugal blood pump affinity cp centrifugal blood pump with balance biosurface affinity cp centrifugal blood pump with cortive bioactive surface medtronic external drive motor
Medtronic
Summary: The Affinity CP Centrifugal Blood Pump by Medtronic is a device used in cardiac surgeries to support extracorporeal circulation. It is typically used by cardiovascular surgeons and perfusionists in operating rooms.
FDA Clearance Information
Pathway
510K
Number
K191077 ↗
Decision Date
August 27, 2019
Product Code
KFM
Device Class
Class 2
Evidence
0 studies
The Affinity CP Centrifugal Blood Pump was cleared through the FDA 510k pathway on August 27, 2019. Manufactured by Medtronic, it is classified as a Class 2 device under product code KFM.
What It Is
The Affinity CP Centrifugal Blood Pump is a medical device designed to facilitate extracorporeal circulation during cardiac surgeries. It utilizes centrifugal force to propel blood through the circuit, minimizing shear stress and reducing the risk of hemolysis. The device incorporates advanced surface coatings like the Balance Biosurface and Cortive Bioactive Surface to enhance biocompatibility and reduce inflammatory responses.
Clinical Applications
This device is commonly used in cardiac surgery settings, particularly during procedures requiring cardiopulmonary bypass. It is essential for maintaining circulation and oxygenation when the heart is temporarily stopped. Cardiovascular surgeons and perfusionists in hospitals and specialized cardiac centers are the primary users. It is suitable for adult and pediatric patients undergoing complex 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 particularly beneficial for reducing complications associated with traditional bypass techniques, such as hemolysis and inflammatory responses.
Practical Considerations
The device is compatible with standard extracorporeal circuit components and is available in various sizes to accommodate different patient needs. Proper setup and alignment with the external drive motor are crucial for optimal performance. Regular monitoring of hemolysis markers is recommended during use.
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, a marker of hemolysis, is associated with multi-organ injury. The study suggests that minimally invasive technologies, like the Affinity CP pump, may help reduce such complications. However, the study was a pilot and had a limited sample size, indicating the need for further research.
Frequently Asked Questions
What is the Affinity CP Centrifugal Blood Pump used for?
It is used for extracorporeal circulation during cardiac surgeries to maintain blood flow and oxygenation when the heart is stopped.
What specialties typically use this device?
Cardiovascular surgeons and perfusionists in cardiac surgery settings use this device.
What are the FDA-cleared indications?
It is indicated for use in patients requiring extracorporeal circulation during cardiac surgery to reduce complications like hemolysis.
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.