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Respiguide Delivery System
Product: Respiguide Delivery System — all models and sizes
Summary: The Respiguide Delivery System by Respicardia is a Class 2 medical device cleared by the FDA for venous-stent applications. Key evidence includes 10 studies, though specific outcomes and safety data are limited.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K130378 ↗
Decision Date ?
October 17, 2013
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Respiguide Delivery System was cleared via the FDA 510(k) pathway on October 17, 2013. It is manufactured by Respicardia and classified as a Class 2 device under product code DQY.
What It Is
The Respiguide Delivery System is designed for the delivery of venous stents. It is intended for use in clinical settings where venous stenting is indicated, providing a mechanism for precise stent placement.
FDA-Cleared Indications
- Delivery and placement of venous stents during percutaneous endovascular procedures.
Clinical Applications
- Delivering a compatible venous stent to a target vein.
- Positioning a venous stent across a venous obstruction or stenosis.
- Supporting venous-stent procedures in the iliac or central venous circulation when clinically indicated.
Evidence Summary
The available literature includes 10 studies, though specific study types and outcomes are not detailed. The studies span from 2017 to 2023, indicating ongoing research interest.
Reported Outcomes
Published studies report limited specific outcomes related to the Respiguide Delivery System. The evidence provided does not include detailed efficacy findings, highlighting a gap in comprehensive outcome data.
Safety Profile
Reported complications include limited safety data from the evidence provided. The studies do not specify adverse events directly related to the Respiguide Delivery System, indicating a need for more focused safety research.
Evidence Limitations
The evidence lacks detailed outcomes and safety data specific to the Respiguide Delivery System. Further research is needed to establish comprehensive efficacy and safety profiles, as well as to explore long-term outcomes.
Practical Considerations
- Use is limited by compatibility with the specific venous stent, guidewire, sheath and access system selected for the procedure.
- The appropriate catheter size and working length depend on the target vessel, access route and stent dimensions; consult the device labeling and instructions for use.
- The system is typically used with fluoroscopic imaging through percutaneous venous access, often from the femoral or jugular vein depending on the anatomy.
- MRI safety and conditional-use requirements should be confirmed for the complete implanted stent system and any retained components; the delivery catheter is removed after deployment.
- Potential risks are related to venous access, catheter manipulation and stent placement, including bleeding, thrombosis, vessel injury, malposition and contrast or radiation exposure.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for Respiguide Delivery System?
The Respiguide Delivery System is indicated for use in venous-stent applications.
What outcomes have been reported in clinical studies?
Specific outcomes related to the Respiguide Delivery System are not detailed in the provided evidence.
What complications have been reported?
The evidence does not specify complications directly related to the Respiguide Delivery System.
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.