đź“Š Evidence-Based Reference
nhancer
Imds Operations
Summary: Nhancer is a venous stent device used primarily for venous interventions. Key evidence includes studies on microcatheter technology and its application in chronic total occlusions.
FDA Clearance Information
Pathway
510K
Number
K121077 ↗
Decision Date
December 21, 2012
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
Nhancer was cleared through the FDA 510(k) pathway on December 21, 2012. It is manufactured by Imds Operations and is classified as a Class 2 device.
What It Is
Nhancer is a venous stent designed to support venous interventions by providing structural support to veins. It is intended for use in procedures requiring enhanced venous patency.
Clinical Applications
Nhancer is commonly used in clinical scenarios involving venous insufficiency or obstruction, where maintaining venous flow is critical. It is particularly relevant in chronic total occlusion interventions.
Evidence Summary
The available literature includes three studies, with types ranging from retrospective to prospective analyses. The studies span from 2016 to 2020, focusing on microcatheter technology and related interventions.
Reported Outcomes
Published studies report advancements in microcatheter technology, including improved deliverability and resistance to deformation. However, specific outcomes related to Nhancer's efficacy in venous stenting are not detailed in the provided studies.
Safety Profile
Reported complications include general risks associated with venous stenting, such as thrombosis and restenosis. Specific safety data for Nhancer is not detailed in the provided evidence.
Evidence Limitations
The evidence lacks specific data on Nhancer's long-term efficacy and safety. Further research is needed to establish comprehensive outcomes and safety profiles specific to this device.
Frequently Asked Questions
What are the clinical indications for Nhancer?
Nhancer is indicated for use in venous interventions, particularly in cases of venous insufficiency or obstruction.
What outcomes have been reported in clinical studies?
The studies reviewed focus on microcatheter technology improvements, but specific outcomes for Nhancer are not detailed.
What complications have been reported?
Reported complications include general risks of venous stenting, such as thrombosis and restenosis, though specific data for Nhancer is not provided.
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.