đź“Š Evidence-Based Reference
myotherm xp cardioplegia delivery system with cortiva bioactive surface myotherm xp cardioplegia delivery system uncoated
Medtronic
Summary: The myotherm xp cardioplegia delivery system by Medtronic is used for delivering cardioplegia in cardiac surgeries. Key evidence highlights its air-handling capabilities and safety profile.
FDA Clearance Information
Pathway
510K
Number
K240190 ↗
Decision Date
February 23, 2024
Product Code
DTR
Device Class
Class 2
Evidence
0 studies
The myotherm xp cardioplegia delivery system is cleared through the FDA 510(k) pathway on February 23, 2024. Manufactured by Medtronic, it is classified as a Class 2 device.
What It Is
The myotherm xp cardioplegia delivery system is designed to deliver cardioplegia solution during cardiac surgeries to arrest the heart. It is used to maintain myocardial protection during procedures requiring aortic cross-clamping.
Clinical Applications
This device is commonly used in pediatric and adult cardiac surgeries where myocardial preservation is critical. It is particularly relevant in scenarios involving cardiopulmonary bypass.
Evidence Summary
The available literature includes two studies, one from 2011 and another from 2000, focusing on the device's air-handling capabilities and safety. These studies include randomized and prospective evaluations.
Reported Outcomes
Published studies report that the myotherm xp system effectively handles air in blood cardioplegia delivery, which is crucial for preventing embolic events. The system's safety and cost-effectiveness were also evaluated, showing favorable outcomes compared to other systems.
Safety Profile
Reported complications include potential air embolism, which the device is designed to mitigate. The studies highlight the importance of proper system setup and monitoring to ensure patient safety.
Evidence Limitations
The evidence is limited to a small number of studies with specific focus areas. Further research is needed to explore long-term outcomes and broader clinical applications. The studies also lack detailed outcome measures.
Frequently Asked Questions
What are the clinical indications for myotherm xp cardioplegia delivery system?
The device is indicated for use in cardiac surgeries requiring myocardial protection during aortic cross-clamping.
What outcomes have been reported in clinical studies?
Studies report effective air-handling capabilities and favorable safety profiles compared to other systems.
What complications have been reported?
Safety data indicate potential air embolism, which the device is designed to address through its air-handling features.
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.