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Reliant Stent Graft Balloon Catheter
Medtronic Endovascular Innovations
Summary: The Reliant Stent Graft Balloon Catheter is a medical device used in endovascular procedures to assist in the placement and expansion of stent grafts. It is primarily used by vascular surgeons and interventional radiologists in the treatment of aortic aneurysms.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K050038 ↗
Decision Date ?
April 13, 2005
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Reliant Stent Graft Balloon Catheter was cleared through the FDA's 510(k) pathway on April 13, 2005. Manufactured by Medtronic Endovascular Innovations, it is classified as a Class 2 device under product code DQY.
What It Is
The Reliant Stent Graft Balloon Catheter is a specialized catheter designed to assist in the deployment and expansion of stent grafts during endovascular procedures. It features an inflatable balloon that helps position and secure the stent graft within the vessel, ensuring proper placement and reducing the risk of migration. This device is crucial in procedures such as endovascular aneurysm repair (EVAR), where precise placement of the stent graft is essential for successful outcomes.
FDA-Cleared Indications
- Use during endovascular procedures that require deployment and expansion of a stent graft within the vascular system.
- Use to assist with positioning, expansion, and fixation of stent grafts during endovascular aortic aneurysm repair.
Clinical Applications
- Molding and expanding stent grafts during endovascular abdominal aortic aneurysm repair (EVAR).
- Molding and expanding stent grafts during endovascular thoracic aortic aneurysm repair (TEVAR), when compatible with the graft system and procedure.
- Helping appose a deployed stent graft to the vessel wall at the seal zones and along the graft body.
- Supporting accurate stent-graft deployment in the aorta under fluoroscopic imaging guidance.
Practical Considerations
- The catheter is available in configurations intended for different vessel diameters and stent-graft dimensions; the treating team selects the size according to the graft system and anatomy.
- It is introduced through a vascular access sheath and used under fluoroscopic imaging. Compatibility with the introducer sheath, guidewire, and selected stent graft must be confirmed before use.
- Inflation must remain within the device's specified volume and pressure limits. Excessive inflation or forceful manipulation can injure the vessel or damage the graft.
- MRI safety depends on the exact device labeling and whether the catheter remains in the patient. The current product instructions should be checked before MRI; an unused or removed catheter does not create an ongoing implanted-device restriction.
- Contraindications, warnings, and limitations include inability to safely obtain vascular access, unsuitable vessel or graft anatomy, and any patient-specific condition that makes endovascular catheterization or balloon inflation unsafe.
Related Literature
The linked study explores endovascular strategies for correcting misplacement of contralateral stent graft limbs during EVAR procedures. It highlights three techniques, including the use of the Reliant Balloon to retract or reposition mispositioned stent grafts. The study emphasizes the importance of these techniques in preventing conversion to open surgery, though it notes that further research is needed to standardize these approaches.
Frequently Asked Questions
What is the Reliant Stent Graft Balloon Catheter used for?
It is used to assist in the deployment and expansion of stent grafts during endovascular procedures, particularly in the treatment of aortic aneurysms.
What specialties typically use this device?
Vascular surgeons and interventional radiologists typically use this device in endovascular procedures.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring the deployment and expansion of stent grafts, particularly in the repair of aortic aneurysms.
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.