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preludeease hydrophilic sheath introducer
Merit Medical Systems
Summary: The PreludeEase Hydrophilic Sheath Introducer is a device designed for vascular access with a hydrophilic coating to enhance deliverability and reduce vessel trauma. Key evidence highlights potential polymer embolization risks.
FDA Clearance Information
Pathway 510K
Number K150257 ↗
Decision Date June 19, 2015
Product Code DYB
Device Class Class 2
Evidence 419 studies
The PreludeEase Hydrophilic Sheath Introducer was cleared via the FDA 510(k) pathway on June 19, 2015. Manufactured by Merit Medical Systems, it is classified as a Class 2 device.
What It Is
The PreludeEase Hydrophilic Sheath Introducer is a medical device used to facilitate vascular access during endovascular procedures. It features a hydrophilic coating intended to improve deliverability and minimize vessel trauma.
Clinical Applications
Commonly used in procedures requiring vascular access, such as embolization with coils or liquid agents. It is particularly useful in navigating tortuous vascular anatomy.
Evidence Summary
The literature includes 10 studies ranging from 2014 to 2023, encompassing various study types such as RCTs and case reports. These studies explore both the efficacy and safety of hydrophilic sheath introducers.
Reported Outcomes
Published studies report that the hydrophilic coating can enhance device deliverability and reduce vessel trauma. However, there is evidence suggesting potential embolization of the polymer coating, which may lead to adverse outcomes.
Safety Profile
Reported complications include polymer embolization, which has been associated with ischemia, infarction, and death. Case reports have documented sterile inflammation and perivascular granulomas at the access site.
Evidence Limitations
The evidence is limited by the small number of studies specifically focusing on the PreludeEase device. Further research is needed to quantify the risks of polymer embolization and to compare outcomes with uncoated devices.
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 PreludeEase Hydrophilic Sheath Introducer?
The device is indicated for use in vascular access during procedures such as embolization with coils or liquid agents.
What outcomes have been reported in clinical studies?
Studies report improved deliverability and reduced vessel trauma, but also potential risks of polymer embolization.
What complications have been reported?
Safety data indicate risks of polymer embolization leading to ischemia, infarction, and death, as well as sterile inflammation at the access site.
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.