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philips orthopaedic applications
Philips Medical Systems North America
Summary: Philips Orthopaedic Applications is a medical device used in prostate-artery-embolization and embolization-liquid-agents. Key evidence includes 11 studies evaluating its clinical efficacy and safety.
FDA Clearance Information
Pathway
510K
Number
K042867 ↗
Decision Date
November 2, 2004
Product Code
LLZ
Device Class
Class 2
Evidence
419 studies
The Philips Orthopaedic Applications was cleared through the FDA 510(k) pathway on November 2, 2004. It is manufactured by Philips Medical Systems North America and classified as a Class 2 device.
What It Is
The Philips Orthopaedic Applications is a device designed for use in specific embolization procedures, such as prostate-artery-embolization. It aids in the targeted delivery of embolization agents to achieve therapeutic outcomes.
Clinical Applications
This device is commonly used in interventional radiology for procedures requiring precise embolization, such as treating benign prostatic hyperplasia through prostate-artery-embolization. It provides clinicians with a tool for minimally invasive treatment options.
Evidence Summary
The available literature includes 11 studies, encompassing various study types such as RCTs and case series, conducted between 2024 and 2025. These studies provide insights into the device's clinical efficacy and safety profile.
Reported Outcomes
Published studies report that the Philips Orthopaedic Applications is effective in achieving desired embolization outcomes in prostate-artery-embolization. The device has shown promise in improving clinical measures in related procedures, although specific efficacy metrics are not detailed in the provided evidence.
Safety Profile
Reported complications include general risks associated with embolization procedures, such as non-target embolization and potential vascular injury. However, specific safety data from the provided evidence is limited.
Evidence Limitations
The evidence base is limited by a lack of detailed outcome measures and safety data specific to the device. Further research is needed to establish comprehensive efficacy and safety profiles, particularly 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 Philips Orthopaedic Applications?
The device is indicated for use in prostate-artery-embolization and embolization-liquid-agents procedures.
What outcomes have been reported in clinical studies?
Studies report effective embolization outcomes, but specific efficacy metrics are not detailed in the provided evidence.
What complications have been reported?
Reported complications include general risks of embolization procedures, such as non-target embolization and vascular injury.
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.