📊 Evidence-Based Reference
Vista Brite Tip Guiding Catheters
Product: Cordis — all models and sizes · Where to buy
Summary: The Vista Brite Tip Guiding Catheters by Cordis are used in coronary and peripheral vascular procedures. Cleared by FDA via 510k in 1997, they are designed for directional atherectomy. Key evidence includes a study evaluating their use in coronary procedures.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K972978 ↗
Decision Date ?
October 21, 1997
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Vista Brite Tip Guiding Catheters were cleared by the FDA through the 510k pathway on October 21, 1997. Manufactured by Cordis, they are classified as Class 2 devices under product code DQY.
What It Is
The Vista Brite Tip Guiding Catheters are medical devices used to facilitate the delivery of interventional tools during coronary and peripheral vascular procedures. They are designed to accommodate atherectomy catheters and provide support for device manipulation.
FDA-Cleared Indications
- Percutaneous catheter use in vascular procedures under the FDA product classification for catheter, percutaneous devices.
- Use as a guiding catheter to facilitate delivery and manipulation of compatible interventional devices within the vasculature.
Clinical Applications
- Providing guiding-catheter support during percutaneous coronary interventions.
- Facilitating delivery of compatible atherectomy catheters during coronary procedures when covered by the applicable device labeling.
- Providing catheter access and support during selected peripheral vascular interventions when the catheter size and configuration are appropriate.
- Supporting advancement and positioning of compatible interventional tools under fluoroscopic imaging.
Reported off-label uses
- Use as a large-lumen support catheter during selected venous interventions, including device delivery for iliac or central venous procedures, may occur in clinical practice but should be evaluated against the specific device labeling.
- Use in mechanical thrombectomy procedures may be considered by clinicians for catheter support or device delivery, but this is not established by the supplied FDA indication text.
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 available literature includes four studies, with one published in 1996 evaluating the catheter's use in coronary procedures. The studies are a mix of clinical trials and evaluations, focusing on cardiology and peripheral artery access.
Reported Outcomes
Published studies report that the Vista Brite Tip Guiding Catheters are effective in providing large lumen access for directional atherectomy. The 1996 study highlighted their capability to accommodate atherectomy catheters, facilitating successful coronary interventions.
Safety Profile
Reported complications include potential ostial trauma and peripheral vascular complications due to the rigidity of the catheter. These issues necessitate careful manipulation during procedures.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of recent data. Further research is needed to evaluate long-term outcomes and safety in diverse patient populations.
Practical Considerations
- Select catheter diameter, length, curve, and lumen size according to the target vessel, access route, guidewire, and interventional device requirements.
- Confirm compatibility with the intended atherectomy or other interventional catheter before use; large-lumen devices may require a larger arterial or venous access sheath.
- Use fluoroscopic or other appropriate imaging guidance and maintain careful wire and catheter control to reduce the risk of dissection, perforation, embolization, thrombosis, or vascular spasm.
- MRI safety depends on the exact catheter model and any retained components; consult the current manufacturer labeling before MRI.
- The catheter is a single-use interventional device and is not intended to remain implanted or to provide long-term vascular access.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for Vista Brite Tip Guiding Catheters?
The catheters are indicated for use in coronary and peripheral vascular procedures, particularly for directional atherectomy.
What outcomes have been reported in clinical studies?
Studies report effective large lumen access for directional atherectomy, with successful coronary interventions noted.
What complications have been reported?
Safety data indicates potential for ostial trauma and peripheral vascular complications due to catheter rigidity.
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.