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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
510K
Number
K050038 ↗
Decision Date
April 13, 2005
Product Code
DQY
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.
Clinical Applications
This device is commonly used in endovascular procedures, particularly in the treatment of abdominal and thoracic aortic aneurysms. Vascular surgeons and interventional radiologists utilize the Reliant Stent Graft Balloon Catheter in hospital settings to ensure accurate deployment of stent grafts. It is particularly beneficial in complex cases where precise positioning is critical to avoid complications such as endoleaks or graft migration.
Indications for Use
The FDA-cleared indications for this device include its use in procedures requiring the deployment and expansion of stent grafts within the vascular system. It is specifically indicated for use in patients undergoing endovascular repair of aortic aneurysms, where precise stent graft placement is necessary.
Practical Considerations
The Reliant Stent Graft Balloon Catheter comes in various sizes to accommodate different vessel diameters and stent graft dimensions. It is compatible with standard introducer sheaths and guidewires used in endovascular procedures. Clinicians should be familiar with the inflation techniques and pressure limits to avoid vessel injury.
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.