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cbmyotherm xp cardioplegia delivery system with carmeda bioactive surface models cb41 and cb41-b
Medtronic Vascular
Summary: The cbmyotherm xp Cardioplegia Delivery System by Medtronic is used to deliver cardioplegia solution during cardiac surgery. It is FDA 510(k) cleared and has been evaluated in studies for its air-handling capabilities and safety.
FDA Clearance Information
Pathway
510K
Number
K003724 ↗
Decision Date
December 21, 2000
Product Code
DTR
Device Class
Class 2
Evidence
0 studies
The cbmyotherm xp Cardioplegia Delivery System was cleared by the FDA through the 510(k) pathway on December 21, 2000. It is manufactured by Medtronic Vascular and classified as a Class 2 device.
What It Is
The cbmyotherm xp Cardioplegia Delivery System is designed to deliver cardioplegia solution to arrest and preserve the heart during cardiac surgery. It features a bioactive surface to enhance compatibility with blood and is intended for use in both adult and pediatric cardiac procedures.
Clinical Applications
This device is commonly used in open heart surgeries to provide myocardial protection by delivering cardioplegia solution. It is particularly useful during aortic cross-clamping and can be integrated into modified ultrafiltration systems post-cardiopulmonary bypass.
Evidence Summary
The available literature includes two studies evaluating the device's performance. These studies, published between 2000 and 2011, include randomized and prospective evaluations focusing on air-handling capabilities and safety.
Reported Outcomes
Published studies report that the cbmyotherm xp system effectively handles air emboli in simulated pediatric models, ensuring safe delivery of cardioplegia. The system's performance was comparable to other cardioplegia delivery devices in terms of safety and cost-effectiveness.
Safety Profile
Reported complications include potential air embolism, which the device is designed to mitigate. The studies did not report significant adverse events directly attributed to the device, indicating a favorable safety profile.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of recent data. Further research is needed to evaluate long-term outcomes and performance in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for cbmyotherm xp Cardioplegia Delivery System?
The device is indicated for delivering cardioplegia solution to arrest the heart during cardiac surgery, particularly in open heart procedures.
What outcomes have been reported in clinical studies?
Studies have reported effective air-handling capabilities and comparable safety and cost-effectiveness to other systems.
What complications have been reported?
Reported complications include potential air embolism, though the device is designed to minimize this risk.
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.