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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 510K
Number K091624 ↗
Decision Date October 15, 2009
Product Code DQY
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.
Clinical Applications
This device is commonly used in scenarios requiring vascular access maintenance, such as in patients undergoing hemodialysis. It is particularly useful in treating stenosis or occlusions in venous structures.
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.
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.