đź“‹ FDA Reference
affinity cp centrifugal blood pump affinity cp centrifugal blood pump with balance biosurface affinity cp centrifugal blood pump with cortiva bioactive surface
Medtronic
Summary: The Affinity CP Centrifugal Blood Pump is a medical device used in cardiac surgeries to support extracorporeal circulation. It is primarily used by cardiothoracic surgeons and perfusionists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K201068 ↗
Decision Date
May 21, 2020
Product Code
KFM
Device Class
Class 2
Evidence
0 studies
The Affinity CP Centrifugal Blood Pump, manufactured by Medtronic, was cleared through the FDA 510(k) pathway on May 21, 2020. It is classified as a Class 2 device under product code KFM.
What It Is
The Affinity CP Centrifugal Blood Pump is a device designed to facilitate extracorporeal circulation during cardiac surgeries. It operates using centrifugal force to pump blood, minimizing damage to blood cells. The device comes with options for Balance Biosurface or Cortiva Bioactive Surface, which are designed to enhance biocompatibility and reduce thrombotic risks.
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 stopped. Cardiothoracic surgeons and perfusionists use it in hospitals to support patients undergoing complex cardiac interventions.
Indications for Use
The Affinity CP Centrifugal Blood Pump is indicated for use in patients undergoing cardiac surgery where extracorporeal circulation is necessary. It is suitable for patients who require temporary circulatory support during surgical procedures.
Practical Considerations
The pump is compatible with various extracorporeal circuit components and is available in different surface coatings to suit patient-specific needs. It is crucial to ensure proper sizing and integration with other circuit elements to optimize performance and patient outcomes.
Related Literature
The linked study compared the hemolysis effects of a magnetic levitation pump versus 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, may help reduce hemolysis. However, as a pilot study, its findings are preliminary and require further validation.
Frequently Asked Questions
What is the Affinity CP Centrifugal Blood Pump used for?
It is used to support extracorporeal circulation during cardiac surgeries, ensuring blood flow and oxygenation when the heart is stopped.
What specialties typically use this device?
Cardiothoracic surgeons and perfusionists in hospital settings typically use this device.
What are the FDA-cleared indications?
It is indicated for use in patients undergoing cardiac surgery where extracorporeal circulation is necessary.
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.