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unballoon non-occlusive modeling catheter
Lemaitre Vascular
Summary: The unballoon non-occlusive modeling catheter by Lemaitre Vascular is designed for venous stent procedures. Cleared by the FDA via 510k pathway, it is supported by 7 studies highlighting its clinical applications and safety profile.
FDA Clearance Information
Pathway
510K
Number
K121839 ↗
Decision Date
August 8, 2012
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The unballoon non-occlusive modeling catheter was cleared by the FDA through the 510k pathway on August 8, 2012. Manufactured by Lemaitre Vascular, it is classified as a Class 2 device.
What It Is
The unballoon non-occlusive modeling catheter is a medical device used in venous stent procedures. It is designed to facilitate the placement and modeling of stents without occluding blood flow, thereby reducing the risk of ischemic complications.
Clinical Applications
This catheter is commonly used in procedures involving venous stents, particularly in scenarios where maintaining blood flow during stent placement is critical. It is applicable in both upper and lower extremity venous interventions.
Evidence Summary
The literature includes 7 studies, comprising various study types such as RCTs and case series, conducted between 2010 and 2021. These studies explore the device's efficacy and safety in clinical settings.
Reported Outcomes
Published studies report that the unballoon non-occlusive modeling catheter effectively supports venous stent placement without significant interruption of blood flow. The device has shown promise in maintaining vessel patency and reducing procedure-related complications.
Safety Profile
Reported complications include minor procedural issues, with no significant adverse events directly attributed to the device. The studies indicate a favorable safety profile, with low incidence of device-related complications.
Evidence Limitations
The evidence is limited by small sample sizes and a lack of long-term follow-up data. Further research is needed to establish the device's efficacy across diverse patient populations and to explore potential long-term outcomes.
Frequently Asked Questions
What are the clinical indications for unballoon non-occlusive modeling catheter?
The device is indicated for use in venous stent procedures, particularly where maintaining blood flow during stent placement is essential.
What outcomes have been reported in clinical studies?
Studies report effective support for venous stent placement with maintained vessel patency and reduced procedural complications.
What complications have been reported?
Reported complications include minor procedural issues, with no significant adverse events directly linked to the device.
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.