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Hi-Torque Pilot 50 and 150 Guide Wire with Hydrocoat Hydrophilic Coating Hi-Torque Whisper Ls and Ms Guide Wire with
Abbott Vascular-Cardiac Therapies
Summary: The hi-torque guide wires by Abbott Vascular are used in cardiovascular procedures to navigate through vessels. They are primarily used by interventional cardiologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K101116 ↗
Decision Date ?
June 23, 2010
Product Code ?
DQX Wire, Guide, Catheter
Device Class ?
Class 2
Evidence ?
419 studies
The hi-torque guide wires were cleared through the FDA 510(k) pathway on June 23, 2010. Manufactured by Abbott Vascular, they are classified as Class 2 devices.
What It Is
The hi-torque guide wires, including the Pilot 50 and 150, as well as the Whisper LS and MS, are designed to assist in navigating through the vascular system during procedures. They feature a hydrophilic coating that enhances maneuverability and reduces friction, making them effective in complex vascular pathways. These guide wires are crucial in procedures requiring precision and control.
FDA-Cleared Indications
- For use with compatible catheters to access and navigate the vascular system during cardiovascular procedures.
- For guiding catheter-based devices through blood vessels during diagnostic or interventional procedures.
- The devices are Class II guide wires classified under 21 CFR 870.1330, with product code DQX.
Clinical Applications
- Guiding catheters through coronary arteries during percutaneous coronary intervention.
- Supporting catheter access during balloon angioplasty procedures.
- Supporting catheter access during coronary stent-placement procedures.
- Navigating tortuous or difficult vascular anatomy during a labeled cardiovascular catheter procedure.
Practical Considerations
- Pilot 50, Pilot 150, Whisper LS, and Whisper MS wires differ in wire characteristics, including support and maneuverability; the appropriate selection depends on anatomy, lesion characteristics, and the compatible catheter system.
- The hydrophilic coating is activated with liquid and can reduce friction, but the wire should be handled according to the manufacturer’s instructions to avoid coating damage.
- Confirm compatibility with the catheter, device, vessel size, and procedural system before use.
- MRI safety depends on the exact model and labeling; do not assume the wire is MRI safe or MRI conditional without checking the current manufacturer instructions for use.
- Potential complications of guide-wire use include vessel injury, dissection, perforation, thrombosis, embolization, infection, and wire fracture or entrapment.
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 is the hi-torque guide wire used for?
It is used to navigate through the vascular system during interventional procedures like angioplasty.
What specialties typically use this device?
Interventional cardiologists primarily use these guide wires.
What are the FDA-cleared indications?
These guide wires are indicated for use in navigating and accessing the vascular system during interventional 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.