đź“Š Evidence-Based Reference
myotherm xp cardioplegia delivery system with cortiva bioactive surface myotherm xp cardioplegia delivery system with cortiva bioactive surface bridge system
Medtronic
Summary: The myotherm xp cardioplegia delivery system with cortiva bioactive surface is used for delivering cardioplegia in cardiac surgeries. It is FDA 510k cleared and has been evaluated in studies focusing on air-handling capabilities and safety.
FDA Clearance Information
Pathway
510K
Number
K162774 ↗
Decision Date
February 10, 2017
Product Code
DTR
Device Class
Class 2
Evidence
0 studies
The myotherm xp cardioplegia delivery system was cleared by the FDA via the 510k pathway on February 10, 2017. It is manufactured by Medtronic and classified as a Class 2 device.
What It Is
The myotherm xp cardioplegia delivery system is designed to deliver cardioplegia solution to arrest the heart during cardiac surgery. It features a cortiva bioactive surface to enhance biocompatibility and is intended for use in procedures requiring myocardial protection.
Clinical Applications
This device is commonly used in open-heart surgeries, particularly in pediatric cases, to provide myocardial protection during aortic cross-clamping. It is also utilized in modified ultrafiltration systems post-cardiopulmonary bypass.
Evidence Summary
The available literature includes two studies, one from 2011 and another from 2000, examining the air-handling capabilities and safety of cardioplegia delivery systems. 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 pediatric cardiac surgeries. The system's safety and cost were also compared to other systems, indicating its competitive performance.
Safety Profile
Reported complications include potential air embolism, which the device is designed to mitigate. The studies did not report significant adverse events directly attributable to the device.
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 compare the device with newer technologies.
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, particularly during aortic cross-clamping.
What outcomes have been reported in clinical studies?
Studies have reported effective air-handling capabilities and competitive safety and cost performance compared to other systems.
What complications have been reported?
Reported complications include potential air embolism, which the device is designed to address.
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.