đź“Š Evidence-Based Reference
m-y sheath
Ram Medical Innovations
Summary: The m-y sheath by Ram Medical Innovations is a Class 2 medical device cleared by the FDA for use in embolization-coils procedures. Key evidence includes 15 studies examining its clinical applications and safety profile.
FDA Clearance Information
Pathway
510K
Number
K190369 ↗
Decision Date
April 17, 2019
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The m-y sheath was cleared via the FDA 510(k) pathway on April 17, 2019. It is manufactured by Ram Medical Innovations and classified as a Class 2 device under product code DYB.
What It Is
The m-y sheath is a medical device designed for use in embolization-coils procedures. It serves as a conduit for delivering embolic agents to targeted vascular sites, facilitating minimally invasive interventions.
Clinical Applications
Commonly used in interventional radiology, the m-y sheath is employed in procedures requiring precise delivery of embolic materials to occlude blood vessels, such as in the treatment of aneurysms or arteriovenous malformations.
Evidence Summary
The available literature includes 15 studies, encompassing various study types such as RCTs and case series, published between 2023 and 2026. These studies provide insights into the device's efficacy and safety.
Reported Outcomes
Published studies report successful use of the m-y sheath in complex left atrial appendage closures and other embolization procedures. Outcomes indicate effective delivery and deployment of embolic agents with minimal procedural complications.
Safety Profile
Reported complications include potential issues related to device navigation and deployment, as well as general risks associated with embolization procedures. However, specific adverse events related to the m-y sheath are not detailed in the provided evidence.
Evidence Limitations
The evidence is limited by the lack of large-scale randomized controlled trials specifically focused on the m-y sheath. Further research is needed to establish long-term outcomes and comparative effectiveness against other devices.
Frequently Asked Questions
What are the clinical indications for m-y sheath?
The m-y sheath is indicated for use in embolization-coils procedures, particularly in interventional radiology for vascular occlusion.
What outcomes have been reported in clinical studies?
Studies report effective use in complex embolization procedures, with successful delivery of embolic agents and minimal complications.
What complications have been reported?
Safety data indicate potential navigation and deployment challenges, but specific complications related to the m-y sheath are not extensively detailed.
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.