đź“Š Evidence-Based Reference
Rim-Haemophilus 1 2
Austin Biological Laboratories
Summary: The rim-haemophilus 1 2 is a clinician-facing device used in embolization-liquid-agents. It was FDA cleared via the 510k pathway in 1983. Key evidence includes 13 studies with a focus on safety and clinical outcomes.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K832051 ↗
Decision Date ?
August 12, 1983
Product Code ?
JST
Device Class ?
Class 1
Evidence ?
419 studies
The rim-haemophilus 1 2 was cleared by the FDA through the 510k pathway on August 12, 1983. It is manufactured by Austin Biological Laboratories and classified as a Class 1 device.
What It Is
The rim-haemophilus 1 2 is a medical device used in the clinical category of embolization-liquid-agents. It is designed for use in specific embolization procedures, providing a mechanism to occlude blood vessels.
FDA-Cleared Indications
- Use in embolization procedures requiring a liquid embolic agent to occlude a blood vessel.
- Use by qualified clinicians when vascular occlusion is needed according to the device labeling.
Clinical Applications
- Delivery or use of a liquid embolic agent during vascular embolization.
- Targeted occlusion of selected blood vessels during an interventional radiology procedure.
- Embolization performed to reduce or stop blood flow in a treated vascular territory.
Evidence Summary
The available literature comprises 13 studies, including various study types such as RCTs and case series, published between 2022 and 2024. These studies provide insights into the device's efficacy and safety.
Reported Outcomes
Published studies report mixed outcomes regarding the efficacy of the rim-haemophilus 1 2. While some studies highlight its effectiveness in achieving desired embolization, others suggest variability in clinical results. The evidence base is diverse, reflecting a range of clinical scenarios.
Safety Profile
Reported complications include potential adverse effects related to the embolization process, such as non-target embolization and local tissue reactions. Safety profiles vary across studies, with some indicating minimal complications.
Evidence Limitations
The evidence base for the rim-haemophilus 1 2 is limited by the variability in study designs and outcomes. Further research is needed to establish standardized protocols and long-term safety data.
Practical Considerations
- The available record does not specify the device's dimensions, catheter compatibility, or the particular liquid embolic agents approved for use; consult the original labeling before use.
- Liquid embolic procedures require imaging guidance and careful control of injection to reduce the risk of unintended embolization.
- MRI safety information is not provided in the available FDA record. Do not assume the device is MR Safe or MR Conditional without manufacturer documentation.
- Contraindications, handling requirements, storage conditions, and preparation instructions should be taken from the original instructions for use.
- Use should be limited to appropriately trained clinicians who can manage procedure-related vascular and embolic complications.
Linked Studies (20)
PubMed • 2025
Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.
Journal of neuroendovascular therapy
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Performance evaluation of quantitative hemoglobin A2 and fetal hemoglobin testing using commercially lyophilized vs. in-house whole blood controls in Chinese clinical laboratories: a 12-year analysis of National External Quality Assessment Data.
Clinical chemistry and laboratory medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Clinical progress note: Haemophilus influenzae type b.
Journal of hospital medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Pilot study of social media promotion of home-based self-testing for syphilis.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Clinical development and performance of the First to Know Syphilis Self-Test for over-the-counter usage: a de novo rapid test for treponemal antibody.
Journal of clinical microbiology
View Source →PubMed • 2025
Implementation of an Opt-Out and Rapid Point-of-Care Syphilis Testing Program for Pregnant Patients Presenting to the Emergency Department.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.
Florida public health review
View Source →PubMed • 2025
Multiplex droplet digital PCR for the detection and quantitation of Streptococcus pneumoniae, Mycoplasma pneumoniae, and Haemophilus influenzae.
Frontiers in cellular and infection microbiology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.
Transboundary and emerging diseases
View Source →PubMed • 2025
Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
View Source →PubMed • 2025
Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.
The Journal of clinical investigation
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.
Hellenic journal of nuclear medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Message from Dr. Philippe T. Georgel, Guest Editor for the Marshall University Collection, Brad D. Smith, President of Marshall University, and Dr. Anivandan Mukherjee, Provost of Marshall University.
Biochemistry and cell biology = Biochimie et biologie cellulaire
View Source →PubMed • 2025
Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.
Journal of Yeungnam medical science
RCT View Source →PubMed • 2025
pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.
Magnetic resonance in medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Comparative connectomics of Drosophila descending and ascending neurons.
Nature
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Hydrophilic-coated sheaths for reducing radial artery spasm during transradial procedures: A systematic review and meta-analysis.
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
View Source →PubMed • 2025
History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.
Zeitschrift fur Rheumatologie
View Source →PubMed • 2025
A Hydrophilic Polyurethane Foam Containing Nigella sativa Oil as a Wound Dressing.
BioMed research international
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What are the clinical indications for rim-haemophilus 1 2?
The clinical indications for rim-haemophilus 1 2 are detailed in the FDA documentation, primarily involving embolization procedures.
What outcomes have been reported in clinical studies?
Clinical studies have reported variable outcomes, with some demonstrating effective embolization and others indicating inconsistent results.
What complications have been reported?
Safety data from evidence indicate complications such as non-target embolization and local tissue reactions.
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.