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Hi-Torque Floppy Guide Wire with Hydrocoat Hydrophilic Coating Hi-Torque Standard Guide Wire with Hydrocoat Hydrophilic
Guidant
Product: Hi-Torque Floppy — all models and sizes
Summary: The hi-torque floppy guide wire with hydrocoat hydrophilic coating is used in interventional cardiology for navigating vascular pathways. Key evidence includes its use in complex procedures like RVOT stenting and PTCA.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K974773 ↗
Decision Date ?
March 13, 1998
Product Code ?
DQX Wire, Guide, Catheter
Device Class ?
Class 2
Evidence ?
419 studies
The hi-torque floppy guide wire was cleared by the FDA via the 510(k) pathway on March 13, 1998. It is manufactured by Guidant and classified as a Class 2 device.
What It Is
The hi-torque floppy guide wire is a medical device designed to assist in navigating vascular pathways during interventional procedures. Its hydrophilic coating aids in smooth passage through blood vessels, making it suitable for complex cardiac interventions.
FDA-Cleared Indications
- Used to facilitate the placement and positioning of intravascular catheters during diagnostic and interventional procedures.
- Intended for navigation through the vascular system under imaging guidance.
- The product code identifies it as a catheter guide wire for use in vascular procedures.
Clinical Applications
- Guiding catheter placement during percutaneous transluminal coronary angioplasty (PTCA).
- Facilitating guide catheter or balloon catheter advancement during coronary interventions.
- Supporting placement of intravascular devices during coronary stenting procedures.
- Navigating tortuous or narrowed coronary vessels during interventional cardiology procedures.
Evidence Summary
The available literature includes a case report from 1991 and a procedural guide from 2025. These studies highlight its application in both coronary angioplasty and right ventricular outflow tract stenting.
Reported Outcomes
Published studies report successful use of the guide wire in PTCA and RVOT stenting. In one case, PTCA was successfully performed on a severe LAD stenosis, though complications arose later.
Safety Profile
Reported complications include coronary arterial rupture during PTCA, with an incidence of 0.13%. Other adverse events noted were transient hypotension and mild to moderate pericardial effusion.
Evidence Limitations
The evidence is limited by the small number of studies and the age of some data. Further research is needed to explore long-term outcomes and broader applications of the device.
Practical Considerations
- The guide wire must be compatible with the intended catheter, device, vessel size and procedural access system.
- Hydrophilic coatings require preparation and handling according to the manufacturer’s instructions; the wire should remain adequately wetted to preserve lubricity.
- Use fluoroscopic or other appropriate imaging guidance, and advance or withdraw the wire gently to reduce the risk of vessel injury, dissection or perforation.
- MRI safety depends on the exact model and labeling; do not assume that this device is MR safe or MR conditional without confirming the product-specific instructions for use.
- As a single-use interventional device, it is not intended to be resterilized or reused.
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 hi-torque floppy guide wire?
The guide wire is indicated for use in interventional cardiology procedures such as PTCA and stenting, particularly in complex vascular pathways.
What outcomes have been reported in clinical studies?
Studies have reported successful navigation and intervention in coronary and RVOT procedures, though some complications were noted.
What complications have been reported?
Safety data indicate complications such as coronary arterial rupture, transient hypotension, and pericardial effusion during PTCA.
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.