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Implant Drivers and TIPS
Miter
Summary: Implant drivers and tips by Miter are used in portal vein procedures. Cleared by FDA in 1978, they are supported by studies on systemic inflammation post-implantation and microanatomic analysis for mechanical amplification.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K781974 ↗
Decision Date ?
December 28, 1978
Product Code ?
DZJ
Device Class ?
Class 2
Evidence ?
0 studies
The implant drivers and tips by Miter were cleared via the FDA 510k pathway on December 28, 1978. They are classified as Class 2 devices under product code DZJ.
What It Is
Implant drivers and tips are surgical tools used to facilitate the placement of implants, particularly in portal vein procedures. They are designed to ensure precise and secure implantation, critical for successful clinical outcomes.
FDA-Cleared Indications
- Used to facilitate placement of an implant during surgery or an interventional procedure, according to the applicable device labeling.
Clinical Applications
- Positioning or advancing an implant during a surgical procedure
- Supporting controlled implant placement when a compatible driver or tip is specified by the manufacturer
Evidence Summary
The literature includes two studies: one from 2025 focusing on systemic inflammation post-TIPS, and another from 2014 analyzing the round window membrane for mechanical amplification. These studies provide insights into device efficacy and anatomical considerations.
Reported Outcomes
Published studies report that decreasing interleukin-6 levels after TIPS implantation can predict outcomes in decompensated cirrhosis. Additionally, microanatomic analysis of the round window membrane suggests potential for improved mechanical amplification with optimized transducer tips.
Safety Profile
Reported complications include potential negative consequences for the round window membrane when using current transducer tips. No specific adverse events were detailed in the studies regarding TIPS-related systemic inflammation.
Evidence Limitations
The evidence is limited by the small number of studies and lack of detailed safety outcomes. Further research is needed to explore long-term safety and efficacy, particularly in diverse patient populations.
Practical Considerations
- The exact compatible implant systems, tip designs, dimensions, and insertion technique must be confirmed in the manufacturer’s instructions for use.
- These instruments should be inspected for damage, cleaned, sterilized, and handled according to the facility’s validated reprocessing protocol.
- The available FDA record does not establish that every model is intended for portal-vein procedures or transjugular intrahepatic portosystemic shunt placement.
- MRI safety depends on the specific instrument, its materials, and whether it is present in or near the MRI scanner; the device should not be taken into the MRI environment without manufacturer documentation.
- Use is contraindicated when the selected driver or tip is incompatible with the implant or when the instrument is damaged, contaminated, or cannot be adequately sterilized.
Frequently Asked Questions
What are the clinical indications for implant drivers and tips?
The clinical indications are detailed in the FDA documentation, primarily involving portal vein procedures such as TIPS.
What outcomes have been reported in clinical studies?
Studies have reported that decreasing interleukin-6 levels post-TIPS can predict outcomes in cirrhosis, and microanatomic analysis suggests potential for improved amplification.
What complications have been reported?
Reported complications include potential negative effects on the round window membrane with current transducer tips, though specific adverse events for TIPS were not detailed.
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.