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endophys pressure sensing sheath
Endophys Holdings
Summary: The Endophys pressure sensing sheath is a device used for invasive blood pressure monitoring during catheterization procedures. Key evidence suggests it may reduce procedure time compared to traditional methods.
FDA Clearance Information
Pathway
510K
Number
K190098 ↗
Decision Date
March 7, 2019
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Endophys pressure sensing sheath was cleared by the FDA through the 510(k) pathway on March 7, 2019. It is manufactured by Endophys Holdings and classified as a Class 2 device.
What It Is
The Endophys pressure sensing sheath is designed to provide real-time invasive blood pressure monitoring during catheterization procedures. It integrates pressure sensing capabilities directly into the sheath, eliminating the need for separate arterial line placement.
Clinical Applications
This device is commonly used in catheterization labs for procedures requiring continuous blood pressure monitoring, such as neurointerventional and embolization procedures. It offers a streamlined approach by reducing the need for additional invasive monitoring setups.
Evidence Summary
The literature includes three studies, with two published in 2018 and one ongoing clinical trial. These studies include randomized controlled trials and comparisons with traditional radial arterial lines.
Reported Outcomes
Published studies report that the pressure sensing sheath may reduce procedure time and improve efficiency compared to radial arterial lines. It also potentially increases anesthetist and patient satisfaction by simplifying the monitoring process.
Safety Profile
Reported complications include potential signal dampening and the inherent risks associated with invasive monitoring. However, specific adverse events were not detailed in the provided studies.
Evidence Limitations
Current evidence is limited by small sample sizes and a lack of long-term outcome data. Further research is needed to confirm the device's efficacy and safety across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for endophys pressure sensing sheath?
The device is indicated for use in procedures requiring continuous invasive blood pressure monitoring, particularly in catheterization and neurointerventional settings.
What outcomes have been reported in clinical studies?
Studies report reduced procedure time and improved efficiency compared to traditional radial arterial lines, with potential increases in satisfaction for both anesthetists and patients.
What complications have been reported?
Reported complications include potential signal dampening and risks associated with invasive monitoring, though specific adverse events were not detailed in the studies.
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.