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unballoon non-occlusive modeling catheter
Lemaitre Vascular
Summary: The unballoon non-occlusive modeling catheter by Lemaitre Vascular is used primarily in venous-stent procedures. It was FDA-cleared via the 510k pathway. Key evidence includes studies on venous recanalization and non-occlusive balloon applications.
FDA Clearance Information
Pathway
510K
Number
K123531 ↗
Decision Date
December 14, 2012
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The unballoon non-occlusive modeling catheter was cleared by the FDA on December 14, 2012, through the 510k pathway. It is manufactured by Lemaitre Vascular and classified as a Class 2 device.
What It Is
The unballoon non-occlusive modeling catheter is designed for use in venous-stent procedures. It allows for modeling without occluding blood flow, which is crucial in maintaining perfusion during interventions.
Clinical Applications
This device is commonly used in procedures involving venous stents, particularly where maintaining blood flow is critical. It is applicable in scenarios such as upper-extremity vein thrombosis and other venous interventions.
Evidence Summary
The literature includes 7 studies, ranging from 2010 to 2021, covering various aspects of non-occlusive catheter use. Study types include RCTs, prospective, and retrospective analyses.
Reported Outcomes
Published studies report that the unballoon non-occlusive modeling catheter is effective in maintaining blood flow during procedures. It has been used successfully in animal models and in vitro settings to demonstrate its utility in venous interventions.
Safety Profile
Reported complications include potential issues with thrombus formation and challenges in optimizing procedural outcomes. However, specific adverse events related to the device are not extensively documented in the provided studies.
Evidence Limitations
The evidence is limited by a lack of large-scale clinical trials directly assessing the device's efficacy and safety. Further research is needed to establish long-term outcomes and to explore its use in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for unballoon non-occlusive modeling catheter?
The device is indicated for use in venous-stent procedures where maintaining blood flow is essential, such as in upper-extremity vein thrombosis.
What outcomes have been reported in clinical studies?
Studies report effective maintenance of blood flow during procedures and successful application in animal models and in vitro settings.
What complications have been reported?
Safety data indicate potential thrombus formation and procedural challenges, but specific adverse events are not extensively documented.
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.