📊 Evidence-Based Reference
Myotherm Xp Cardioplegia Delivery System with Trillium Biosurface Myotherm Xp Cardioplegia Delivery System with Trillium Biosurface with Bridge Myotherm Xp Cardioplegia Delivery System Myotherm Xp Cardioplegia Delivery System with Bridge
Summary: The Myotherm XP Cardioplegia Delivery System by Medtronic is designed for delivering cardioplegia solutions during cardiac surgery. It is FDA 510k cleared and has been evaluated in studies focusing on air-handling capabilities and safety.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K162958 ↗
Decision Date ?
February 1, 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 1, 2017. It is manufactured by Medtronic and classified as a Class 2 device under product code DTR.
What It Is
The Myotherm XP Cardioplegia Delivery System is a medical device used to deliver cardioplegia solutions to arrest and preserve the heart during cardiac surgery. It is equipped with Trillium Biosurface technology to enhance biocompatibility.
FDA-Cleared Indications
- Used during cardiac surgery to deliver cardioplegia solution to the heart.
- Intended to provide controlled delivery of cardioplegia during procedures requiring myocardial protection.
- Available in configurations with a Trillium Biosurface coating and/or bridge.
Clinical Applications
- Delivery of cardioplegia solution during adult cardiac surgery.
- Delivery of cardioplegia solution during pediatric cardiac surgery.
- Myocardial protection during aortic cross-clamping and cardiopulmonary bypass.
- Integration with compatible cardiopulmonary bypass circuits according to the device labeling.
Evidence Summary
The available literature includes two studies, one from 2011 and another from 2000, evaluating 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 Cardioplegia Delivery System effectively manages air emboli in simulated pediatric models. Additionally, it has been compared to other systems for safety and cost-effectiveness in clinical settings.
Safety Profile
Reported complications include potential air emboli, which the device is designed to handle effectively. Safety evaluations have compared it to other systems, highlighting its reliability in clinical use.
Evidence Limitations
The evidence is limited by the small number of studies and the focus on specific aspects like air-handling and cost. Further research is needed to explore long-term outcomes and broader clinical applications.
Practical Considerations
- The system is used with a compatible cardiopulmonary bypass circuit, cardioplegia solution, and perfusion equipment; compatibility should be confirmed before use.
- Available configurations may differ by tubing arrangement, bridge option, heat-exchanger configuration, and Trillium Biosurface treatment.
- It is a single-use device and should be inspected, primed, and managed according to the manufacturer's instructions for use.
- The device is used in the operating room with trained cardiac-surgery and perfusion staff; potential concerns include air entry, leaks, clotting, obstruction, inadequate flow, and temperature-control problems.
- MRI safety should not be assumed. The system is generally not present during MRI, and the current labeling should be reviewed if any component could remain in or near the patient.
Frequently Asked Questions
What are the clinical indications for Myotherm XP Cardioplegia Delivery System?
The device is indicated for use in cardiac surgeries to deliver cardioplegia solutions for myocardial protection during aortic cross-clamping.
What outcomes have been reported in clinical studies?
Studies have reported effective air-handling capabilities and favorable safety profiles compared to other systems.
What complications have been reported?
Safety data indicate potential air emboli, which the device is designed to manage effectively.
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.