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Albunex R Echocardiography Contrast Microspheres
Molecular Biosystems
Summary: Albunex R Echocardiography Contrast Microspheres are used to enhance ultrasound imaging of the heart. Primarily used in echocardiography to improve visualization of cardiac structures. Key evidence suggests improved Doppler signal intensity and myocardial perfusion assessment.
FDA Clearance Information
Pathway ?
PMA
Number ?
P900059 ↗
Decision Date ?
March 1, 1996
Product Code ?
MJS
Device Class ?
Class 3
Evidence ?
0 studies
Albunex R Echocardiography Contrast Microspheres were cleared by the FDA via the PMA pathway on March 1, 1996. Manufactured by Molecular Biosystems, it is classified as a Class 3 device.
What It Is
Albunex R is a contrast agent composed of microspheres used in echocardiography to enhance ultrasound imaging. It is intended to improve the visualization of cardiac structures and blood flow, aiding in the assessment of cardiac function.
FDA-Cleared Indications
- Approval addressed release of the final product using USP sterility testing performed by Molecular Biosystems rather than NAMSA, Irvine, California.
- The device was approved through the PMA pathway under product code MJS.
Clinical Applications
- Enhancement of ultrasound images during echocardiography
- Improved visualization of cardiac chambers and structures
- Improved assessment of intracardiac blood flow and Doppler signals
Evidence Summary
The literature includes 10 studies, comprising RCTs, prospective, and retrospective analyses, conducted between 1997 and 2003. These studies explore various clinical applications of Albunex R in echocardiography.
Reported Outcomes
Published studies report that Albunex R enhances Doppler signal intensity in patients with prosthetic aortic valves and improves the quantification of left ventricular volumes and function. It also aids in assessing myocardial perfusion during cardiac procedures.
Safety Profile
Reported complications include potential microvascular injury and inflammation, as the microspheres may adhere to activated neutrophils. However, specific adverse events were not detailed in the provided studies.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of detailed safety data. Further research is needed to fully understand the long-term safety and efficacy of Albunex R in diverse patient populations.
Practical Considerations
- Albunex R is an echocardiography contrast microsphere product; the available FDA record does not provide a current labeled size range or detailed composition in the supplied indication text.
- Administration and imaging should follow the product labeling and institutional echocardiography protocols.
- The available FDA indication text primarily addresses sterility-release testing rather than a detailed clinical indication, so historical labeling should be reviewed before clinical use.
- This is an ultrasound contrast agent, not an MRI contrast agent; MRI compatibility should not be inferred from its echocardiography use.
- Patient-specific contraindications, precautions, and adverse reactions should be checked in the applicable labeling before administration.
Frequently Asked Questions
What are the clinical indications for Albunex R Echocardiography Contrast Microspheres?
Albunex R is indicated for use in echocardiography to enhance ultrasound imaging of the heart, particularly in patients with suboptimal echocardiograms.
What outcomes have been reported in clinical studies?
Studies have reported improved Doppler signal intensity and enhanced assessment of myocardial perfusion and left ventricular function.
What complications have been reported?
Reported complications include potential microvascular injury and inflammation, although specific adverse events were not detailed in the studies.
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.