📋 FDA Reference
Torqvue Low Profile Delivery Catheter
Aga Medical Corporation (Wholly Owned By St.Jude Medical Cor
Summary: The TorqVue Low Profile Delivery Catheter is a medical device used for the delivery of venous stents. It is primarily used by interventional radiologists and cardiologists in procedures involving venous access.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K162228 ↗
Decision Date ?
September 9, 2016
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The TorqVue Low Profile Delivery Catheter was cleared via the FDA 510(k) pathway on September 9, 2016. It is manufactured by Aga Medical Corporation, a subsidiary of St. Jude Medical, and is classified as a Class 2 device.
What It Is
The TorqVue Low Profile Delivery Catheter is a specialized catheter designed to facilitate the delivery of venous stents. It features a low-profile design that allows for easier navigation through the venous system. The catheter is engineered to provide precise control and placement of stents, which is critical in ensuring optimal patient outcomes.
FDA-Cleared Indications
- Delivery of compatible venous stents during percutaneous endovascular procedures.
Clinical Applications
- Delivering a compatible venous stent to a planned treatment site.
- Positioning a venous stent across a venous obstruction when stent treatment is indicated.
- Supporting venous stent placement in iliac or central venous interventions.
Practical Considerations
- The catheter must be matched to the intended venous stent, guidewire, vessel size and access route according to the device labeling.
- Available catheter sizes and working lengths should be reviewed before the procedure to ensure compatibility with the patient's anatomy and the selected stent.
- Placement is performed under imaging guidance, commonly through percutaneous venous access, with fluoroscopy used to confirm catheter and stent position.
- Clinicians should follow the manufacturer's instructions for preparation, advancement, stent loading and deployment; excessive force can injure the vessel or damage the device.
- MRI safety depends on the specific catheter and whether it remains in the patient. The current device labeling should be checked before MRI, and a single-use delivery catheter is generally removed after stent deployment.
Procedures that use this device
Frequently Asked Questions
What is the TorqVue Low Profile Delivery Catheter used for?
It is used for the delivery of venous stents in interventional procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use this device.
What are the FDA-cleared indications?
The device is indicated for delivering venous stents, particularly in cases of venous obstruction or insufficiency.
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.