Supercross Microcatheter Supercross Ft Microcatheter Supercross at Microcatheter
Product: Supercross — all models and sizes
FDA Clearance Information
The Supercross Microcatheter was cleared through the FDA 510(k) pathway on April 30, 2021. It is manufactured by Vascular Solutions and is classified as a Class 2 medical device.
What It Is
FDA-Cleared Indications
- Intended for percutaneous introduction into the vasculature to access selected blood vessels.
- Used to facilitate the placement and delivery of compatible interventional devices, including venous stents, during endovascular procedures.
- The specific indication, anatomy, and compatible devices depend on the applicable model and manufacturer labeling.
Clinical Applications
- Selective catheterization of veins during endovascular procedures.
- Vascular access and support for iliac or central venous stent placement when compatible with the stent system.
- Navigation through complex venous anatomy under fluoroscopic imaging.
- Support of guidewire and device delivery during treatment of appropriately selected venous obstruction.
Reported off-label uses
- Selective catheterization in arterial interventions when the specific model, anatomy, and device labeling permit its use.
- Delivery of embolic agents or other therapeutic materials in selected vascular procedures when used outside the labeled venous-stent application.
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.
Practical Considerations
- Available sizes, lengths, tip configurations, and guidewire compatibility vary by Supercross model; clinicians should confirm the current product labeling before use.
- The catheter is advanced over a compatible guidewire under fluoroscopic or other appropriate imaging guidance and should not be forced through resistance.
- Use only with compatible guidewires, introducer sheaths, stents, and delivery systems specified by the manufacturer.
- MRI safety depends on the exact model and product labeling; do not assume the catheter is MR Safe or MR Conditional without confirming the manufacturer’s current instructions.
- General contraindications and risks include unsuitable vascular anatomy, vessel injury, bleeding, infection, thrombosis, embolization, and catheter damage or entrapment.
Procedures that use this device
Frequently Asked Questions
What is the Supercross Microcatheter used for?
The Supercross Microcatheter is used for navigating complex vascular pathways and is primarily utilized in procedures involving the placement of venous stents.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use the Supercross Microcatheter in vascular intervention procedures.
What are the FDA-cleared indications?
The device is indicated for use in procedures involving venous stents, suitable for treating venous obstructions or thrombosis.