📊 Evidence-Based Reference
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 ?
510(k)
Number ?
K123531 ↗
Decision Date ?
December 14, 2012
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- For percutaneous catheter procedures in the vascular system, consistent with the FDA product code DQY and 21 CFR 870.1250.
- For non-occlusive modeling of vascular stents when maintaining blood flow during the intervention is clinically important.
Clinical Applications
- Non-occlusive modeling of venous stents after stent placement.
- Percutaneous treatment of venous-stent configurations in which complete balloon occlusion is undesirable.
- Modeling of stents in the iliac and central venous circulation under fluoroscopic guidance.
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.
Practical Considerations
- The catheter must be matched to the treated vessel, stent dimensions, guidewire, and introducer sheath; available sizes and compatibility should be confirmed in the current manufacturer instructions for use.
- It is intended to permit blood flow during modeling, but it does not eliminate the risks of catheterization, wire manipulation, stent deformation, thrombosis, embolization, bleeding, or vessel injury.
- Use requires imaging guidance, typically fluoroscopy, and appropriate anticoagulation or antiplatelet management based on the procedure and patient.
- MRI safety and conditional-use information depend on the exact catheter model and labeling. Confirm the current manufacturer MRI instructions before scanning; do not assume the device is MRI safe.
- Contraindications and warnings include inability to safely access the target vessel, significant vessel injury or infection at the access site, and allergy or intolerance to materials or contrast used during the procedure.
Procedures that use this device
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.