AngioJet Ultra Dvx Thrombectomy Set Model 106552-001 AngioJet Ultra Xpeedior Thrombectomy Set Model 105040-001

FDA-Cleared Indications

• Removal of thrombi from the venous system.

Clinical Applications

• Endovascular removal of acute venous thrombi in selected patients with deep vein thrombosis.
• Venous thrombectomy performed by interventional radiology or vascular surgery teams.
• Removal of thrombus from selected large veins when catheter-based treatment is clinically appropriate.

Reported off-label uses

• Mechanical thrombectomy for selected pulmonary embolism cases, depending on the specific catheter labeling, anatomy, and institutional protocol.
• Thrombectomy of dialysis grafts or fistulas with access-circuit-specific devices or configurations, when not covered by the exact FDA-cleared indication for this set.

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 record identifies the AngioJet Ultra DVX thrombectomy set, model 106552-001, and AngioJet Ultra Xpeedior thrombectomy set, model 105040-001.
• The system uses high-pressure saline jets and aspiration; operators must follow the device-specific instructions for catheter preparation, guidewire compatibility, flow settings, and treatment time.
• The exact catheter diameter, working length, and compatible access equipment vary by model and should be confirmed in the current instructions for use.
• Contraindications, warnings, and precautions may include unsuitable vessel size or anatomy, inability to safely cross the thrombus, bleeding risk, and conditions in which thrombolysis or mechanical thrombectomy is inappropriate.
• These catheters should not be assumed to be MRI safe. MRI compatibility depends on the specific catheter and generator components; verify the current labeling before an MRI examination.