018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter
Creagh Medical Ltd. Dba Surmodics
Product: Advance Serenity 18 Hydrophilic PTA Balloon Dilatation Catheter — all models and sizes · Where to buy · Find similar PTA balloons by size
FDA Clearance Information
The device was cleared through the FDA 510(k) pathway on November 15, 2024. Manufactured by Creagh Medical Ltd., it is classified as a Class 2 device under product code LIT.
What It Is
FDA-Cleared Indications
- Percutaneous transluminal angioplasty of stenotic peripheral blood vessels.
- Dilation of narrowed peripheral vessels in adult patients who require endovascular treatment.
- Use in peripheral vascular interventions where balloon catheter dilation is indicated.
Clinical Applications
- Balloon angioplasty of stenotic peripheral arteries.
- Treatment of peripheral arterial narrowing associated with peripheral artery disease.
- Dilation of a narrowed vessel after guidewire access during an endovascular procedure.
- Use in catheterization laboratories or vascular procedure suites for peripheral vessel intervention.
Practical Considerations
- The catheter is an over-the-wire device and requires a compatible guidewire and an access sheath or guiding catheter appropriate for the selected size.
- Available balloon diameter, length, shaft length, profile, and rated pressure should be matched to the target vessel and lesion.
- The hydrophilic coating is intended to reduce friction during advancement, but the catheter should be flushed, handled, and advanced according to the manufacturer's instructions.
- Balloon inflation should remain within the manufacturer's specified pressure limits; angiographic imaging is used to confirm positioning and treatment effect.
- MRI safety depends on the specific device configuration and labeling. The manufacturer's current instructions for use should be reviewed before MRI, and the catheter 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 018 hydrophilic coated OTW PTA balloon dilatation catheter used for?
It is used to dilate narrowed blood vessels, particularly in the treatment of peripheral artery disease.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in endovascular procedures.
What are the FDA-cleared indications?
The device is indicated for dilating stenotic segments of blood vessels to improve blood flow in patients with peripheral vascular diseases.