Ekos Peripheral Infusion System

FDA-Cleared Indications

• Infusion of thrombolytic agents into thrombus during catheter-directed thrombolysis.
• Ultrasound-assisted delivery of thrombolytic medication to a localized blood clot.
• Treatment of thrombotic vascular conditions in which mechanical thrombolysis or catheter-directed clot treatment is indicated.

Clinical Applications

• Catheter-directed thrombolysis for selected deep vein thrombosis.
• Treatment of selected acute limb ischemia caused by arterial thrombus.
• Local thrombolytic treatment of thrombosed vascular segments under fluoroscopic imaging.
• Use with an appropriately selected thrombolytic agent according to the device and drug labeling.

Reported off-label uses

• Catheter-directed treatment of selected pulmonary embolism cases using ultrasound-assisted thrombolysis.
• Treatment of thrombosed dialysis grafts or fistulas in conjunction with thrombectomy and other access-revision techniques.

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 catheter must be selected to match the treated vessel, clot length, access route, and compatible guidewire and infusion components; available sizes and treatment lengths depend on the specific system configuration.
• The device is used with fluoroscopic imaging and an appropriate thrombolytic medication. Anticoagulation, bleeding risk, renal function, and the need for blood-product monitoring should be assessed before treatment.
• Important contraindications and precautions include active bleeding, recent major surgery or trauma, intracranial hemorrhage or other major bleeding risk, and hypersensitivity or contraindication to the selected thrombolytic drug.
• MRI compatibility is configuration-specific. Confirm the current device labeling before MRI; the system should not be assumed to be safe for MRI while implanted or connected.
• Treatment duration varies with clot burden, anatomy, medication, and response. Catheter-directed thrombolysis requires monitoring for bleeding and other complications, and may be followed by angioplasty, stenting, thrombectomy, or surgery when needed.