đź“Š Evidence-Based Reference
Vipercross Support Catheters
Summary: Vipercross support catheters are used in venous stenting procedures. They are designed to provide support during catheterization. Key evidence suggests bundled strategies reduce infection risk.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K211240 ↗
Decision Date ?
August 26, 2021
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Vipercross support catheters were cleared by the FDA through the 510(k) pathway on August 26, 2021. Manufactured by Cardiovascular Systems, they are classified as Class 2 devices.
What It Is
Vipercross support catheters are medical devices used to facilitate the placement of stents in venous procedures. They provide structural support to guide other instruments during catheterization.
FDA-Cleared Indications
- Percutaneous catheter use to provide support during intravascular procedures.
- Facilitation of catheterization and navigation within blood vessels.
- Use with compatible guidewires and interventional devices when catheter support is needed.
Clinical Applications
- Providing support during endovascular catheterization.
- Helping operators navigate compatible instruments through the vascular system.
- Supporting access and device delivery during selected venous interventions when consistent with the device labeling.
- Providing catheter backup during complex vascular access procedures.
Reported off-label uses
- Use as a support catheter in selected arterial interventions is described for support-catheter devices, but the specific use must be verified against the current product labeling.
- Use in challenging access or crossing situations outside the labeled indication may occur in clinical practice; this is physician-directed off-label use and is not established by the supplied FDA summary.
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 10 studies, ranging from randomized controlled trials to retrospective analyses, published up to 2024. These studies explore infection control and device efficacy in vascular procedures.
Reported Outcomes
Published studies report that the use of bundled strategies with support catheters can decrease infection rates across various devices. However, specific efficacy outcomes related to Vipercross catheters are not detailed in the provided evidence.
Safety Profile
Reported complications include infection risks associated with catheter use, comparable to those of short-term, non-cuffed central venous catheters. Proper care and infection control measures are emphasized.
Evidence Limitations
The evidence lacks specific outcomes directly related to Vipercross support catheters. Further research is needed to establish detailed efficacy and safety profiles specific to this device.
Practical Considerations
- Select the catheter size, length, and configuration according to the target vessel, access route, guidewire, and device being delivered.
- Confirm compatibility with the guidewire, introducer sheath, contrast agent, and other interventional equipment before use.
- Use fluoroscopic or other appropriate imaging guidance and follow the manufacturer's instructions for preparation, flushing, advancement, and withdrawal.
- The supplied FDA record does not state an MRI safety classification; MRI conditions should be confirmed in the current labeling before scanning.
- Potential catheter-related complications include vascular injury, bleeding, thrombosis, embolization, infection, dissection, and vessel perforation. Contraindications and warnings should be taken from the current instructions for use.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for Vipercross support catheters?
Vipercross support catheters are indicated for use in venous stenting procedures, providing support during catheterization.
What outcomes have been reported in clinical studies?
Studies suggest that bundled strategies reduce infection risk, but specific outcomes for Vipercross catheters are not detailed.
What complications have been reported?
Reported complications include infection risks similar to those of other vascular access devices, emphasizing the need for proper care.
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.