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Stent Graft Balloon Catheter
Via Biomedical
Summary: The stent graft balloon catheter by Via Biomedical is used primarily for vascular interventions, such as maintaining hemodialysis access. Key evidence highlights its role in endovascular procedures to prevent access failure.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K091624 ↗
Decision Date ?
October 15, 2009
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The stent graft balloon catheter was cleared by the FDA through the 510(k) pathway on October 15, 2009. It is manufactured by Via Biomedical and classified as a Class 2 device.
What It Is
The stent graft balloon catheter is a medical device used in endovascular procedures to support vessel patency. It combines a stent graft with a balloon catheter to facilitate the placement and expansion of the stent within the vessel.
FDA-Cleared Indications
- For percutaneous placement and expansion of a stent graft within a blood vessel.
- For treatment of vascular stenosis or occlusion when endovascular stent-graft placement is clinically appropriate.
- For maintaining or restoring patency of vascular access, including hemodialysis access, according to the specific device labeling.
Clinical Applications
- Endovascular placement and balloon expansion of a vascular stent graft.
- Treatment of stenosis in a vascular access circuit used for hemodialysis.
- Treatment of selected venous stenoses or occlusions requiring covered stent placement.
- Percutaneous maintenance or restoration of vascular access patency.
Reported off-label uses
- Treatment of selected central venous stenoses outside the device's specific labeled indication.
- Use in venous stenting procedures involving iliac or other large veins when the device is not specifically labeled for that anatomy.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The literature includes 15 studies, comprising various study types such as RCTs, prospective, and retrospective analyses. The studies span from 2021 to 2023, focusing on the device's application in vascular access maintenance.
Reported Outcomes
Published studies report that the stent graft balloon catheter is effective in maintaining vascular access patency, particularly in hemodialysis patients. It has been shown to successfully treat stenosis and prevent access failure, with technical success reported in multiple cases.
Safety Profile
Reported complications include the potential for stent migration and vessel injury. However, the studies generally indicate a favorable safety profile with low incidence of severe adverse events.
Evidence Limitations
The evidence is limited by a lack of large-scale randomized controlled trials. Most studies are small and retrospective, highlighting the need for further research to establish long-term efficacy and safety.
Practical Considerations
- The catheter, guidewire, sheath, and stent-graft dimensions must be compatible with the target vessel and the planned access route.
- Use requires fluoroscopic or other appropriate imaging guidance, sterile technique, and careful vessel sizing before deployment.
- Balloon inflation pressure and duration must follow the device instructions for use; excessive inflation can injure the vessel or damage the stent graft.
- MRI conditions depend on the specific stent-graft and catheter components. The implanted stent graft should be evaluated using its current labeling before an MRI examination.
- Contraindications and precautions include unsuitable vessel size or anatomy, inability to safely obtain vascular access, active infection at the treatment site, and allergy or intolerance to contrast or device materials.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for stent graft balloon catheter?
The device is indicated for use in maintaining vascular access, particularly in patients requiring hemodialysis, and in treating venous stenosis.
What outcomes have been reported in clinical studies?
Clinical studies have reported successful maintenance of vascular access patency and effective treatment of stenosis, with technical success in multiple cases.
What complications have been reported?
Safety data from evidence indicate potential complications such as stent migration and vessel injury, though these are relatively infrequent.
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.