Ekosonic Mach 4 Endovascular Device Ekosonic Control Unit

FDA-Cleared Indications

• Used for ultrasound-assisted catheter-directed thrombolysis in the treatment of venous thromboembolism.
• Intended to facilitate the infusion and penetration of thrombolytic medication into venous thrombi.
• Used in the venous system under fluoroscopic guidance by appropriately trained clinicians.

Clinical Applications

• Catheter-directed thrombolysis for selected acute deep vein thrombosis.
• Ultrasound-assisted thrombolysis for selected pulmonary embolism cases.
• Treatment of venous thromboembolism when expedited clot treatment is clinically appropriate.
• Use in interventional radiology or vascular surgery procedures with concomitant thrombolytic medication.

Reported off-label uses

• Treatment of thrombosed dialysis grafts or fistulas may be performed with ultrasound-assisted thrombolysis systems, but the specific indication depends on the device labeling and procedure.
• Use in other venous thromboses outside the cleared indication may be reported in clinical practice, but requires clinician judgment and institutional oversight.

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 size and treatment length must match the affected vessel and the extent of thrombus.
• The system is used with an appropriate thrombolytic agent; medication selection, dose and infusion duration are determined by the treating clinician.
• Placement and treatment require fluoroscopic imaging, sterile technique and clinicians trained in catheter-directed thrombolysis.
• Contraindications and precautions include factors that increase bleeding risk, contraindications to thrombolytic medication, and unsuitable vascular anatomy.
• MRI safety depends on the specific device components and whether they remain in or near the patient; the applicable FDA labeling and manufacturer MRI conditions should be checked before scanning.