Penumbra System Ace

FDA-Cleared Indications

• Intended for the percutaneous removal of thrombus or embolus from blood vessels.
• Used with compatible aspiration and catheter systems to retrieve intravascular clot under imaging guidance.
• Use is limited to the vessels, patient populations, and configurations specified in the applicable FDA-cleared labeling.

Clinical Applications

• Percutaneous aspiration thrombectomy for selected venous thrombi.
• Mechanical thrombectomy for selected deep vein thrombosis cases when the device configuration and labeling permit.
• Thrombus removal from selected occluded vascular access circuits, such as dialysis grafts or fistulas, when used according to applicable labeling.
• Catheter-based clot removal in other labeled vascular applications determined by the specific ACE model and instructions for use.

Reported off-label uses

• Aspiration thrombectomy for pulmonary embolism has been reported in clinical practice for selected patients, but use must be verified against the specific device labeling and institutional protocol.
• Aspiration thrombectomy for acute ischemic stroke has been reported for compatible Penumbra systems and configurations; the exact ACE device and indication should not be assumed to be interchangeable with dedicated neurovascular systems.

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

• ACE catheters are available in different inner diameters and working lengths; the appropriate size depends on vessel diameter, clot burden, access route, and the compatible aspiration pump or tubing.
• The catheter is advanced over a guidewire or through a compatible guiding or sheath system under fluoroscopic imaging. Adequate vascular access and compatibility must be confirmed before use.
• MRI safety depends on the exact device configuration and whether the catheter is in place. Follow the current product labeling and institutional MRI policy; do not assume the system is safe for MRI.
• Potential complications include vessel injury, perforation, bleeding, distal embolization, infection, contrast reaction, and access-site complications.
• Contraindications and warnings vary by model and indication. Review the current FDA-cleared instructions for use, including restrictions related to vessel size, anticoagulation, access, and inability to safely cross the clot.