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Progigy Support Catheter
Radius Medical
Summary: The Progigy Support Catheter by Radius Medical is a Class 2 device cleared by the FDA for use in venous stenting procedures. Key evidence highlights its role in managing catheter-related complications.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K130714 ↗
Decision Date ?
August 22, 2013
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Progigy Support Catheter was cleared through the FDA 510(k) pathway on August 22, 2013. It is manufactured by Radius Medical and classified as a Class 2 device.
What It Is
The Progigy Support Catheter is designed to facilitate the placement and support of venous stents. It is used in interventional procedures to manage venous obstructions and improve blood flow.
FDA-Cleared Indications
- Used to support and facilitate the placement of venous stents during percutaneous endovascular procedures.
- Intended for use in the venous vasculature.
Clinical Applications
- Providing catheter support during venous stent delivery and deployment.
- Facilitating endovascular treatment of venous obstruction when placement of a venous stent is indicated.
- Supporting access and device positioning during iliac or central venous stenting procedures.
Evidence Summary
The literature includes 9 studies, encompassing various study designs such as RCTs and retrospective analyses, published between 2024 and 2025. These studies explore the catheter's role in managing venous complications.
Reported Outcomes
Published studies report that the Progigy Support Catheter is effective in supporting venous stenting procedures, with outcomes indicating improved blood flow and reduced venous pressure. However, the heterogeneity of study designs and patient populations limits the generalizability of these findings.
Safety Profile
Reported complications include catheter-related thrombosis and infection. The studies highlight the importance of proper catheter management and infection control measures to mitigate these risks.
Evidence Limitations
The evidence is limited by small sample sizes and non-uniform study designs. Further research is needed to establish standardized protocols and long-term outcomes of using the Progigy Support Catheter.
Practical Considerations
- The appropriate catheter size, length, and compatibility depend on the access route, target vessel, guidewire, and venous stent system being used.
- The catheter is used under imaging guidance by trained clinicians; careful manipulation is needed to reduce the risk of vessel injury, dissection, perforation, thrombosis, or bleeding.
- MRI safety should be confirmed from the current device labeling and manufacturer documentation before scanning. Do not assume the catheter is MR safe or MR conditional based only on its FDA clearance.
- Use is contraindicated or inappropriate when the planned access route, vessel anatomy, device compatibility, or patient condition does not support safe catheter placement.
- This is a temporary procedural device and is not intended to remain implanted after the procedure.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for Progigy Support Catheter?
The Progigy Support Catheter is indicated for use in venous stenting procedures to manage venous obstructions and improve blood flow.
What outcomes have been reported in clinical studies?
Studies report improved blood flow and reduced venous pressure following the use of the Progigy Support Catheter in venous stenting procedures.
What complications have been reported?
Complications such as catheter-related thrombosis and infection have been reported, emphasizing the need for proper management and infection control.
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.