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the unballoon non-occlusive catheter the unballoon non-occlusive modeling catheter
Lemaitre Vascular
Summary: The unballoon non-occlusive catheter by Lemaitre Vascular is designed for venous stent procedures. Cleared by FDA via 510k pathway. Key evidence highlights its use in non-occlusive procedures.
FDA Clearance Information
Pathway
510K
Number
K110891 ↗
Decision Date
September 13, 2011
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The unballoon non-occlusive catheter was cleared by the FDA through the 510k pathway on September 13, 2011. Manufactured by Lemaitre Vascular, it is classified as a Class 2 device.
What It Is
The unballoon non-occlusive catheter is a medical device used in venous stenting procedures. It allows for non-occlusive modeling of vessels, facilitating interventions without complete vessel occlusion.
Clinical Applications
Commonly used in venous stenting, the device is particularly beneficial in scenarios where vessel occlusion is undesirable or challenging. It provides a means to perform interventions while maintaining blood flow.
Evidence Summary
The literature includes 9 studies, with a mix of RCTs, prospective, and retrospective analyses. The studies span from 2022 to 2025, providing insights into the device's efficacy and safety.
Reported Outcomes
Published studies report that the unballoon non-occlusive catheter is effective in maintaining vessel patency during procedures. It is particularly useful in large pulmonary vein isolation and non-occlusive coronary angioscopy. The device's design supports successful outcomes in complex vascular interventions.
Safety Profile
Reported complications include non-occlusive mesenteric ischemia and challenges in deployment in certain anatomical conditions. However, the overall safety profile is favorable, with few adverse events noted in the literature.
Evidence Limitations
The evidence is limited by a lack of large-scale randomized controlled trials. Further research is needed to explore long-term outcomes and compare efficacy with alternative devices.
Frequently Asked Questions
What are the clinical indications for the unballoon non-occlusive catheter?
The device is indicated for use in venous stenting procedures, particularly where non-occlusive techniques are preferred.
What outcomes have been reported in clinical studies?
Studies report effective vessel patency and successful intervention outcomes, especially in large pulmonary vein isolation and coronary angioscopy.
What complications have been reported?
Safety data indicate rare occurrences of non-occlusive mesenteric ischemia and deployment challenges in specific anatomical conditions.
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.