Penumbra Ddc Catheters

FDA-Cleared Indications

• Percutaneous removal of thrombus from blood vessels when catheter-based treatment is indicated.
• Use in the vascular system under imaging guidance by appropriately trained clinicians.
• The specific indication, anatomy, catheter size, and technique must be confirmed in the applicable Penumbra instructions for use.

Clinical Applications

• Catheter-based thrombectomy for selected deep vein thrombosis cases when the device labeling and anatomy are appropriate.
• Thrombectomy of selected thrombosed dialysis grafts or fistulas, when covered by the applicable device labeling.
• Removal of thrombus from a treated venous segment as part of an endovascular procedure.
• Use with venography or other vascular imaging to guide catheter positioning and assess blood-flow restoration.

Reported off-label uses

• Use in selected pulmonary embolism thrombectomy procedures may be reported in clinical practice, but the applicable device-specific labeling should be checked before use.
• Use in other venous territories or clot burdens outside the cleared indication may occur in practice but should not be assumed to be FDA-cleared.

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

• Select catheter diameter and length based on the target vessel, clot burden, access route, and compatibility with guidewires, sheaths, and any aspiration or thrombectomy system used.
• Access is commonly obtained through a peripheral vein, dialysis access circuit, or another vascular entry site, with fluoroscopy and contrast venography used for navigation and assessment.
• The procedure may involve local anesthesia with moderate sedation or, in selected cases, general anesthesia; duration and hospital stay depend on the clot location and the patient's condition.
• Review the current instructions for use for contraindications, vessel-size requirements, pressure limits, compatibility, and warnings about perforation, bleeding, embolization, and device malfunction.
• MRI safety is device- and configuration-specific. Do not assume the catheter or any retained component is MR Safe or MR Conditional without checking the current labeling.