Scorpion Portal Vein Access Set

FDA-Cleared Indications

• Access to the portal vein for percutaneous interventional procedures.
• Use in procedures requiring entry into the hepatic portal venous system under imaging guidance.

Clinical Applications

• Obtaining portal vein access for portal vein embolization.
• Establishing portal venous access for diagnostic evaluation of the hepatic portal venous system.
• Providing access for therapeutic procedures involving the portal vein when the device is used according to its FDA-cleared labeling.

Reported off-label uses

• Portal venous access during selected portal hypertension interventions, when clinically appropriate and performed by an experienced specialist.
• Portal venography or other portal venous interventions beyond the specific procedure described in the device labeling.

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

• The set is intended for use by trained clinicians with ultrasound, fluoroscopy, or other appropriate imaging guidance.
• Confirm the available needle and catheter sizes, working length, and compatibility with guidewires, sheaths, embolic agents, and other planned equipment before the procedure.
• Use caution in patients with uncorrected coagulopathy, severe thrombocytopenia, infection along the access route, or anatomy that makes portal venous puncture unsafe; the treating physician determines contraindications.
• MRI safety information is device- and component-specific. Check the current Argon Medical Devices instructions for use and labeling before exposing the set or any retained component to an MRI environment.
• The set is generally a single-use device and should not be resterilized or reused unless the labeling specifically permits it.