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vista brite tip catheters
Cordis
Summary: Vista Brite Tip Catheters are used primarily for directional coronary atherectomy. Key evidence highlights their compatibility with atherectomy catheters and potential to reduce vascular complications.
FDA Clearance Information
Pathway
510K
Number
K965211 ↗
Decision Date
March 11, 1997
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Vista Brite Tip Catheters were cleared via the FDA 510(k) pathway on March 11, 1997. Manufactured by Cordis, they are classified as Class 2 devices.
What It Is
Vista Brite Tip Catheters are guiding catheters designed for use in directional coronary atherectomy. They feature a large lumen and are intended to accommodate atherectomy catheters, facilitating coronary interventions.
Clinical Applications
These catheters are commonly used in cardiology for procedures requiring directional coronary atherectomy. They are particularly useful in scenarios where large lumen access is necessary to accommodate atherectomy devices.
Evidence Summary
The available literature includes four studies, with one published in 1996 and three ongoing PMCF studies. These studies focus on 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. They are noted for their large lumen, which accommodates atherectomy catheters and may reduce the risk of vascular complications.
Safety Profile
Reported complications include potential ostial trauma and peripheral vascular complications due to the rigidity of the catheter. However, the design aims to mitigate these risks by accommodating atherectomy catheters effectively.
Evidence Limitations
The evidence is limited by the small number of published studies and the preliminary nature of available data. Further research is needed to fully understand long-term outcomes and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Vista Brite Tip Catheters?
Vista Brite Tip Catheters are indicated for use in directional coronary atherectomy, particularly in cases requiring large lumen access.
What outcomes have been reported in clinical studies?
Clinical studies have reported effective facilitation of directional coronary atherectomy with reduced vascular complications.
What complications have been reported?
Reported complications include ostial trauma and peripheral vascular complications, although the catheter design aims to minimize these risks.
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.