đź“Š Evidence-Based Reference
Cardiac Function Laboratory Pressure Interface Pressure Volume Catheter
Cd Leycom
Summary: The cardiac function laboratory pressure interface pressure volume catheter by Cd Leycom is a device used for assessing cardiac function. It was FDA cleared via 510k in 2001. Key evidence includes studies on cardiac hypertrophy and bioelectronics.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K003020 ↗
Decision Date ?
May 11, 2001
Product Code ?
DQO Catheter, Intravascular, Diagnostic
Device Class ?
Class 2
Evidence ?
0 studies
The device was cleared by the FDA through the 510k pathway on May 11, 2001. It is manufactured by Cd Leycom and classified as a Class 2 device under product code DQO.
What It Is
This device is a catheter designed to interface with pressure volume systems in cardiac function laboratories. It is intended for the assessment of cardiac function by measuring pressure-volume relationships in the heart.
FDA-Cleared Indications
- For use as an intravascular diagnostic catheter in cardiac function laboratory pressure-volume measurement systems.
- For measuring intracardiac pressure-volume relationships during assessment of cardiac function.
Clinical Applications
- Invasive pressure-volume assessment of cardiac performance.
- Hemodynamic evaluation in a cardiac function laboratory.
- Measurement of intracardiac pressure and volume relationships during diagnostic cardiac studies.
Evidence Summary
The literature includes 15 studies, with a mix of RCTs, prospective, and retrospective designs. The studies span from 2024 to 2026, focusing on cardiac hypertrophy and bioelectronics.
Reported Outcomes
Published studies report advancements in understanding cardiac hypertrophy and the potential of piezo-electronics in bioelectronics. However, specific efficacy outcomes related to the catheter itself are not detailed in the provided evidence.
Safety Profile
Reported complications include general risks associated with catheterization, but specific adverse events related to this device are not detailed in the provided evidence.
Evidence Limitations
The evidence lacks specific outcomes directly related to the catheter's efficacy and safety. Further research is needed to establish detailed clinical outcomes and safety profiles.
Practical Considerations
- The catheter must be compatible with the intended pressure-volume analysis system and associated recording equipment.
- Use requires vascular access and image-guided or physiologic monitoring expertise appropriate for invasive cardiac catheterization.
- The access route, catheter dimensions, and positioning depend on the cardiac chamber or vessel being evaluated and the clinical protocol.
- MRI safety should be confirmed from the current device labeling; do not assume the catheter or connected equipment is MR Safe or MR Conditional.
- Risks are those of invasive intravascular catheterization and may include bleeding, infection, vascular injury, arrhythmia, thrombus, embolization, and cardiac perforation.
Frequently Asked Questions
What are the clinical indications for cardiac function laboratory pressure interface pressure volume catheter?
The device is indicated for use in cardiac function laboratories to assess cardiac performance by measuring pressure-volume relationships.
What outcomes have been reported in clinical studies?
Studies have focused on cardiac hypertrophy and bioelectronics, but specific outcomes related to the catheter are not detailed.
What complications have been reported?
Reported complications include general risks of catheterization; specific adverse events for this device are 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.