đź“Š Evidence-Based Reference
viapeel peelable introducer
Enpath Medical
Summary: The Viapeel Peelable Introducer by Enpath Medical is a Class 2 device used primarily for vascular access procedures. Key evidence highlights its role in reducing air embolism risk during catheter insertion.
FDA Clearance Information
Pathway
510K
Number
K072248 ↗
Decision Date
November 9, 2007
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Viapeel Peelable Introducer was cleared by the FDA via the 510(k) pathway on November 9, 2007. It is manufactured by Enpath Medical and classified as a Class 2 device.
What It Is
The Viapeel Peelable Introducer is a medical device designed to facilitate the insertion of catheters into the vascular system. It features a peelable sheath that allows for easy removal after catheter placement, minimizing the risk of air embolism.
Clinical Applications
This device is commonly used in procedures requiring central venous access, such as the placement of central venous catheters for hemodialysis or other long-term intravenous therapies.
Evidence Summary
The available literature includes three studies ranging from 2006 to 2021, comprising retrospective observational studies and bench-top evaluations. These studies focus on the device's safety and efficacy in clinical settings.
Reported Outcomes
Published studies report that the Viapeel Peelable Introducer effectively reduces the risk of air embolism during catheter insertion. The device's design facilitates safer and more efficient vascular access, particularly in challenging anatomical scenarios.
Safety Profile
Reported complications include the potential for air embolism, which the device is specifically designed to mitigate. No significant adverse events were noted in the reviewed studies.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of large-scale randomized controlled trials. Further research is needed to confirm long-term safety and efficacy across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Viapeel Peelable Introducer?
The device is indicated for use in procedures requiring central venous access, such as the insertion of central venous catheters for hemodialysis.
What outcomes have been reported in clinical studies?
Studies report that the device reduces the risk of air embolism and facilitates safer catheter placement.
What complications have been reported?
Reported complications include the risk of air embolism, which the device aims to reduce.
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.