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sheets lyophilized collagen heyedrator
Pantheon Products
Summary: The sheets lyophilized collagen heyedrator by Pantheon Products is a Class 1 medical device cleared by the FDA for clinical use. It is primarily used in embolization procedures as a liquid agent. Key evidence highlights its biocompatibility and potential in wound healing applications.
FDA Clearance Information
Pathway
510K
Number
K861456 ↗
Decision Date
July 25, 1986
Product Code
HMP
Device Class
Class 1
Evidence
419 studies
The sheets lyophilized collagen heyedrator was cleared through the FDA 510(k) pathway on July 25, 1986. Manufactured by Pantheon Products, it is classified as a Class 1 device under product code HMP.
What It Is
The device is a lyophilized collagen sheet designed for rehydration and use in clinical settings. It functions as a biocompatible scaffold, primarily intended for use in embolization procedures as a liquid agent. The collagen is derived from porcine sources and processed to ensure safety and efficacy.
Clinical Applications
Commonly used in embolization procedures, the device serves as a liquid agent to aid in the occlusion of blood vessels. It is also explored for its potential in wound healing applications, leveraging its biocompatibility and structural properties.
Evidence Summary
The available literature includes 10 peer-reviewed studies, with a mix of RCTs, prospective, and retrospective studies. The studies span from 2019 to 2025, focusing on the device's biocompatibility, wound healing potential, and antibacterial properties.
Reported Outcomes
Published studies report that the device demonstrates significant biocompatibility, with in vitro and in vivo tests showing minimal cytotoxicity and irritation. It has shown promise in wound healing applications, particularly when combined with antibacterial agents. The device's structural properties support its use as a scaffold in tissue engineering.
Safety Profile
Reported complications include minimal adverse reactions in biocompatibility tests, with no significant sensitization or irritation observed. The studies highlight the device's safety profile, particularly in controlled clinical environments.
Evidence Limitations
The evidence is limited by the small sample sizes and the early-stage nature of some studies. Further research is needed to explore long-term outcomes and the device's efficacy in diverse clinical scenarios. The current literature lacks large-scale RCTs to fully establish its clinical benefits.
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 sheets lyophilized collagen heyedrator?
The device is indicated for use in embolization procedures as a liquid agent, with potential applications in wound healing.
What outcomes have been reported in clinical studies?
Studies report effective biocompatibility and potential in wound healing, with minimal cytotoxicity and irritation observed.
What complications have been reported?
Reported complications include minimal adverse reactions, with no significant sensitization or irritation in biocompatibility tests.
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.