đź“‹ FDA Reference

platinum plus guidewire with hydrophilic coating

Boston Scientific

Summary: The Platinum Plus Guidewire with hydrophilic coating is a medical device used primarily in interventional radiology and vascular procedures. It is designed to assist clinicians in navigating through blood vessels during embolization procedures.

FDA Clearance Information

Pathway 510K
Decision Date June 5, 1995
Product Code DQX
Device Class Class 2
Evidence 419 studies

The Platinum Plus Guidewire by Boston Scientific was cleared through the FDA 510k pathway on June 5, 1995. It is classified as a Class 2 medical device under product code DQX.

What It Is

The Platinum Plus Guidewire is a flexible wire with a hydrophilic coating that enhances its maneuverability within the vascular system. This coating reduces friction, allowing the guidewire to navigate through complex vascular pathways with ease. It is used to guide catheters and other devices to the target site within the body, facilitating various interventional procedures.

Clinical Applications

This guidewire is commonly used in interventional radiology and vascular surgery, particularly during embolization procedures to treat conditions such as varicose veins or vascular malformations. It is suitable for use in both hospital and outpatient settings, and is typically employed by interventional radiologists and vascular surgeons. The device is beneficial for patients requiring precise navigation through tortuous vascular anatomy.

Indications for Use

The FDA indications for this guidewire include its use in procedures involving embolization with liquid agents. This means it is intended for patients who require the occlusion of blood vessels, often to treat or prevent abnormal blood flow or bleeding.

Practical Considerations

The Platinum Plus Guidewire is available in various lengths and diameters to accommodate different procedural needs. Its hydrophilic coating requires activation with a saline solution to maximize its lubricity. Clinicians should ensure compatibility with other devices used in the procedure, such as catheters and embolic agents.

Related Literature

The linked study, 'Complications of Gonadal Veins Embolization,' likely explores the adverse events associated with embolization procedures using devices like the Platinum Plus Guidewire. Although the abstract is unavailable, such studies typically focus on identifying and mitigating risks during embolization. Limitations may include a lack of detailed outcome data or small sample sizes.

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

Editorial - Philippe Ascher (1936-2022).

Neuroscience

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 is the Platinum Plus Guidewire used for?

It is used to guide catheters and other devices through the vascular system during interventional procedures, such as embolization.

What specialties typically use this device?

Interventional radiologists and vascular surgeons commonly use this device.

What are the FDA-cleared indications?

It is indicated for use in procedures involving embolization with liquid agents to occlude blood vessels.

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.

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