Acs Hi-Torque Cross It 100xt 200xt and 300xt Guide Wires with Hydrocoat Hydrophilic Coating
Guidant
FDA Clearance Information
The ACS Hi-Torque Cross It guide wires were cleared through the FDA 510(k) pathway on March 25, 1999, by Guidant. They are classified as Class 2 medical devices.
What It Is
FDA-Cleared Indications
- Intended for use as a guide wire in the vasculature during diagnostic and interventional procedures.
- Used to facilitate placement and positioning of catheters and other interventional devices.
- The FDA classification and product code identify the device as a catheter guide wire; specific clinical uses should follow the manufacturer’s cleared labeling.
Clinical Applications
- Guiding balloon catheters during percutaneous coronary intervention.
- Facilitating placement of coronary stents and other interventional devices.
- Navigating narrowed, tortuous, or otherwise difficult vascular segments during catheter-based procedures.
- Supporting catheter positioning during diagnostic or interventional cardiac catheterization.
Practical Considerations
- The 100XT, 200XT, and 300XT versions have different support and handling characteristics; the appropriate wire should be selected for the lesion, vessel anatomy, and planned device.
- Hydrophilic coatings can reduce friction but may also reduce tactile feedback and require careful manipulation under fluoroscopic guidance.
- Compatibility with the intended catheter, balloon, stent-delivery system, and other equipment should be confirmed before use.
- Use sterile technique and avoid excessive force, sharp angulation, or uncontrolled wire movement because guide wires can dissect or perforate a vessel, fracture, or become trapped.
- MRI safety status is not established by the 510(k) record alone. The exact device labeling should be checked before MRI, and the wire should not be assumed to be MRI safe.
Linked Studies (20)
Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.
Journal of neuroendovascular therapy
RCT|prospective|retrospective|case Series|other View Source →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 →Clinical progress note: Haemophilus influenzae type b.
Journal of hospital medicine
RCT|prospective|retrospective|case Series|other View Source →Pilot study of social media promotion of home-based self-testing for syphilis.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →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 →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 →Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.
Florida public health review
View Source →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 →Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.
Transboundary and emerging diseases
View Source →Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
View Source →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 →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 →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 →Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.
Journal of Yeungnam medical science
RCT View Source →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 →Comparative connectomics of Drosophila descending and ascending neurons.
Nature
RCT|prospective|retrospective|case Series|other View Source →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 →History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.
Zeitschrift fur Rheumatologie
View Source →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 ACS Hi-Torque Cross It Guide Wires used for?
These guide wires are used in interventional cardiology to navigate through blood vessels during procedures like angioplasty.
What specialties typically use this device?
Interventional cardiologists primarily use these guide wires in cardiac catheterization labs.
What are the FDA-cleared indications?
These guide wires are indicated for use in procedures requiring vascular navigation, particularly for treating blocked arteries.