đź“‹ FDA Reference
Smartguide Deflectable Hydrophilic Guidewire
Product: SmartGUIDE deflectable hydrophilic guidewire — all models and sizes
Summary: The Smartguide Deflectable Hydrophilic Guidewire is a medical device used primarily in interventional radiology and endovascular procedures to navigate complex vascular anatomy. It is typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K222690 ↗
Decision Date ?
April 24, 2023
Product Code ?
MOF
Device Class ?
Class 2
Evidence ?
419 studies
The Smartguide Deflectable Hydrophilic Guidewire by Artiria Medical was cleared through the FDA 510(k) pathway on April 24, 2023. It is classified as a Class 2 device under product code MOF.
What It Is
The Smartguide Deflectable Hydrophilic Guidewire is a specialized medical tool designed to assist in navigating the vascular system during minimally invasive procedures. It features a hydrophilic coating that enhances its maneuverability through blood vessels, and its deflectable tip allows for precise direction control. This guidewire is particularly useful in accessing difficult-to-reach areas within the vascular system, making it a valuable tool in complex interventions.
FDA-Cleared Indications
- Used to facilitate the delivery of liquid embolization agents to selected vascular targets.
- Used during endovascular procedures that require controlled navigation through the vasculature for liquid embolization.
- The specific FDA-cleared indication should be confirmed in the device's current instructions for use.
Clinical Applications
- Navigation and catheter positioning during procedures that deliver liquid embolic agents.
- Endovascular treatment of selected vascular lesions when liquid embolization is indicated.
- Accessing tortuous or difficult vascular anatomy during an on-label liquid embolization procedure.
Practical Considerations
- The guidewire is available in different lengths and diameters; the appropriate size depends on the access route, catheter system and target anatomy.
- Its hydrophilic coating reduces friction when wet. The wire should be prepared and handled according to the instructions for use so the coating is not damaged or allowed to dry.
- The deflectable tip requires familiarity with the control mechanism and careful manipulation under fluoroscopic imaging.
- Compatibility with the intended catheter and liquid embolic delivery system must be confirmed before use.
- MRI safety and conditional-use information should be checked in the current labeling; do not assume the device is MR safe based only on its hydrophilic coating.
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 Smartguide Deflectable Hydrophilic Guidewire used for?
It is used for navigating the vascular system during interventional procedures, particularly when delivering embolization agents to treat conditions like aneurysms.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in endovascular and interventional radiology procedures.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring precise vascular navigation and delivery of embolization agents, such as in the treatment of vascular malformations.
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.