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Medtronic
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
510K
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.
Clinical Applications
This device is commonly used in pediatric and adult cardiac surgeries to maintain 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, 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.
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.