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Intravascular Catheter with Hydrophilic Coating
Summary: The intravascular catheter with hydrophilic coating by Boston Scientific is primarily used for embolization procedures. Key evidence highlights its antifouling properties and potential complications related to polymer embolism.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K891580 ↗
Decision Date ?
August 3, 1989
Product Code ?
DQO Catheter, Intravascular, Diagnostic
Device Class ?
Class 2
Evidence ?
419 studies
The device was cleared through the FDA 510(k) pathway on August 3, 1989. It is manufactured by Boston Scientific and classified as a Class 2 medical device.
What It Is
This device is an intravascular catheter with a hydrophilic coating designed to reduce friction and improve maneuverability within blood vessels. It is intended for use in embolization procedures and other vascular interventions.
FDA-Cleared Indications
- Intravascular diagnostic use within the vascular system.
- Vascular access and navigation during procedures when specified by the individual catheter labeling.
- Use in embolization procedures only when the specific cleared catheter labeling identifies embolization as an intended use.
Clinical Applications
- Diagnostic catheterization of blood vessels.
- Selective catheter placement in peripheral vessels.
- Vascular access during image-guided endovascular procedures.
- Embolization procedures when authorized by the specific product's FDA-cleared labeling.
Evidence Summary
The literature includes 15 studies, encompassing various study types such as RCTs and case series, published between 2022 and 2024. These studies explore the device's efficacy and safety in clinical settings.
Reported Outcomes
Published studies report that the hydrophilic coating on the catheter enhances antifouling properties, reducing protein and cell adhesion. This can potentially lower the risk of thrombosis and improve device retrieval.
Safety Profile
Reported complications include hydrophilic polymer embolism, where the coating may separate and cause adverse reactions. Other issues include the risk of the catheter becoming stuck during procedures, leading to potential vessel damage.
Evidence Limitations
Current evidence is limited by the small number of large-scale RCTs and a lack of long-term outcome data. Further research is needed to fully understand the long-term safety and efficacy of the hydrophilic coating in diverse patient populations.
Practical Considerations
- Available sizes, lengths, tip shapes, guidewire compatibility, and maximum injection pressure vary by model; confirm the product labeling before use.
- The hydrophilic coating should be activated and maintained according to the manufacturer's instructions. Improper handling can damage the coating or impair catheter performance.
- Potential complications include vessel injury, bleeding, thrombosis, infection, catheter damage, and separation or embolization of coating material.
- MRI safety is model-specific. Check the exact device labeling for MR Safe, MR Conditional, or MR Unsafe status before MRI.
- Contraindications and precautions depend on the specific catheter, intended anatomy, contrast agent, and procedure; review the instructions for use before use.
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 intravascular catheter with hydrophilic coating?
The device is indicated for use in embolization procedures and other vascular interventions requiring smooth navigation through blood vessels.
What outcomes have been reported in clinical studies?
Studies report enhanced antifouling properties and reduced risk of thrombosis due to the hydrophilic coating.
What complications have been reported?
Safety data indicate risks of hydrophilic polymer embolism and potential catheter entrapment during procedures.
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.