Summary: Vista Brite Tip Catheters are used for guiding catheter procedures, primarily in cardiology and peripheral interventions. Key evidence includes studies evaluating their use in directional coronary atherectomy and peripheral artery procedures.
The Vista Brite Tip Catheters were cleared by the FDA via the 510(k) pathway on October 17, 1996. Manufactured by Cordis, they are classified as Class 2 devices under product code DQY.
What It Is
The Vista Brite Tip Catheters are guiding catheters designed for use in interventional cardiology and peripheral vascular procedures. They facilitate the introduction of interventional devices into the vasculature.
Clinical Applications
These catheters are commonly used in procedures such as directional coronary atherectomy and interventions involving peripheral arteries, both above and below the knee. They are integral in providing access and support for various interventional tools.
Evidence Summary
The available literature includes four studies, with publication years ranging from 1996 to recent clinical trials. These studies encompass evaluations of the catheter's use in cardiology and peripheral artery procedures.
Reported Outcomes
Published studies report that the Vista Brite Tip Catheters are effective in facilitating directional coronary atherectomy and peripheral artery interventions. The studies highlight their capability to accommodate atherectomy catheters and provide adequate support during procedures.
Safety Profile
Reported complications include potential ostial trauma and peripheral vascular complications due to the rigidity of the catheter. However, specific adverse events were not detailed in the provided evidence.
Evidence Limitations
The evidence is limited by the small number of studies and lack of detailed outcomes and safety data. Further research is needed to fully understand the long-term efficacy and safety profile of these catheters.
Frequently Asked Questions
What are the clinical indications for Vista Brite Tip Catheters?
Vista Brite Tip Catheters are indicated for use in interventional cardiology and peripheral vascular procedures, including directional coronary atherectomy and peripheral artery interventions.
What outcomes have been reported in clinical studies?
Clinical studies have reported that the catheters are effective in facilitating directional coronary atherectomy and peripheral artery interventions, providing necessary support for interventional devices.
What complications have been reported?
Reported complications include potential ostial trauma and peripheral vascular complications, though specific adverse events were not detailed in the provided studies.
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.
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