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flexseal introducer sheath with hydrophilic coating
Freudenberg Medical Mis
Summary: The Flexseal Introducer Sheath with hydrophilic coating is used for vascular access in embolization procedures. Key evidence highlights its role in minimizing vessel trauma and improving deliverability.
FDA Clearance Information
Pathway 510K
Number K190628 ↗
Decision Date May 30, 2019
Product Code DYB
Device Class Class 2
Evidence 419 studies
The Flexseal Introducer Sheath was cleared by the FDA via the 510(k) pathway on May 30, 2019. It is manufactured by Freudenberg Medical Mis and classified as a Class 2 device.
What It Is
The Flexseal Introducer Sheath is a medical device with a hydrophilic coating designed to facilitate vascular access by reducing friction during insertion. It is primarily used in embolization procedures to introduce catheters and other devices into the vascular system.
Clinical Applications
Commonly used in procedures involving embolization coils and liquid agents, the Flexseal Introducer Sheath is utilized in scenarios requiring smooth and atraumatic vascular access, particularly in complex or tortuous vascular anatomies.
Evidence Summary
The available literature includes 10 studies ranging from case reports to pilot studies, published between 2021 and 2023. These studies explore various aspects of hydrophilic coatings and their impact on device performance and safety.
Reported Outcomes
Published studies report that the hydrophilic coating on the Flexseal Introducer Sheath enhances deliverability and reduces vessel trauma. However, there are concerns about potential polymer embolization, which could lead to adverse outcomes.
Safety Profile
Reported complications include the potential for hydrophilic polymer embolization, which may result in ischemia, infarction, or death. These findings highlight the importance of monitoring for adverse events during and after procedures.
Evidence Limitations
The evidence is limited by the small number of studies specifically focused on the Flexseal Introducer Sheath. Further research is needed to fully understand the long-term safety and efficacy of the hydrophilic coating in diverse clinical settings.
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 flexseal introducer sheath?
The Flexseal Introducer Sheath is indicated for use in vascular access during embolization procedures involving coils and liquid agents.
What outcomes have been reported in clinical studies?
Studies have reported improved deliverability and reduced vessel trauma due to the hydrophilic coating, although concerns about polymer embolization exist.
What complications have been reported?
Safety data indicate potential complications such as hydrophilic polymer embolization, which can lead to serious adverse events like ischemia and infarction.
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.