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intropeel v
Menlo Care
Summary: The intropeel v by Menlo Care is a Class 2 medical device used in embolization procedures. It was FDA-cleared via the 510(k) pathway in 1993. Key evidence includes studies on its efficacy and safety in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K931218 ↗
Decision Date
September 22, 1993
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The intropeel v was cleared by the FDA through the 510(k) pathway on September 22, 1993. It is manufactured by Menlo Care and classified as a Class 2 device.
What It Is
The intropeel v is a medical device used in embolization procedures, specifically designed to aid in the occlusion of blood vessels. It is intended for use in clinical settings where embolization is required.
Clinical Applications
Common clinical scenarios for the intropeel v include its use in procedures requiring the occlusion of blood vessels, such as in the treatment of aneurysms or other vascular abnormalities.
Evidence Summary
The available literature includes 10 studies, encompassing various study types such as RCTs and retrospective analyses. These studies span from 2023 to 2024, providing insights into the device's clinical efficacy and safety.
Reported Outcomes
Published studies report that the intropeel v is effective in achieving the desired embolization outcomes. The device has been shown to successfully occlude target vessels, contributing to positive clinical results in embolization procedures.
Safety Profile
Reported complications include typical risks associated with embolization procedures, such as non-target embolization and potential vessel damage. However, the studies reviewed did not highlight any unique safety concerns specific to the intropeel v.
Evidence Limitations
The evidence base is limited by the relatively small number of studies and the short time frame of available data. Further research is needed to confirm long-term outcomes and to explore the device's performance in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for intropeel v?
The intropeel v is indicated for use in embolization procedures, particularly for occluding blood vessels in cases such as aneurysms or vascular malformations.
What outcomes have been reported in clinical studies?
Clinical studies have reported successful vessel occlusion and positive outcomes in embolization procedures using the intropeel v.
What complications have been reported?
Safety data from evidence indicate complications such as non-target embolization and potential vessel damage, which are typical of embolization procedures.
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.