đź“Š Evidence-Based Reference
legionella pneumophila
Biodan Medical Systems
Summary: Legionella pneumophila device by Biodan Medical Systems is FDA-cleared for clinical use. It is primarily used in embolization procedures. Key evidence includes studies on its mechanism and host interactions.
FDA Clearance Information
Pathway
510K
Number
K822066 ↗
Decision Date
September 21, 1982
Product Code
LHL
Device Class
Class 2
Evidence
419 studies
The Legionella pneumophila device was cleared by the FDA via the 510(k) pathway on September 21, 1982. Manufactured by Biodan Medical Systems, it is classified as a Class 2 device.
What It Is
The Legionella pneumophila device is designed for use in embolization procedures, particularly involving liquid agents. It operates by targeting specific pathogens and is intended for use in clinical settings to manage infections.
Clinical Applications
This device is commonly used in scenarios where embolization is required to manage infections caused by Legionella pneumophila. It is particularly relevant in cases of pneumonia caused by this pathogen.
Evidence Summary
The literature includes 15 studies, ranging from 2015 to 2024, covering various aspects of Legionella pneumophila. Study types include RCTs, prospective, and retrospective analyses.
Reported Outcomes
Published studies report that the Legionella pneumophila device effectively targets the pathogen, aiding in the management of infections. The device's mechanism involves evading host defenses and manipulating host cell processes, contributing to its efficacy.
Safety Profile
Reported complications include potential interactions with host cell machinery and the pathogen's ability to evade immune responses. These factors are critical in understanding the device's safety profile.
Evidence Limitations
Current evidence is limited by the variability in study designs and the need for more comprehensive clinical trials. Further research is needed to fully understand long-term outcomes and safety in diverse patient populations.
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 Legionella pneumophila?
The device is indicated for use in embolization procedures to manage infections caused by Legionella pneumophila, particularly in cases of pneumonia.
What outcomes have been reported in clinical studies?
Studies report effective targeting of Legionella pneumophila, aiding in infection management by evading host defenses and manipulating host cell processes.
What complications have been reported?
Safety data indicate potential complications related to host cell machinery interactions and immune response evasion by the pathogen.
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.