Helo Max Thrombectomy System (HEL2090)
FDA Clearance Information
FDA-Cleared Indications
- Removal of thrombus or embolus from peripheral blood vessels.
- Use with aspiration to restore blood flow in vessels affected by acute or subacute thrombosis or embolic occlusion.
- Intended for use by physicians trained in endovascular procedures.
Clinical Applications
- Mechanical thrombectomy for deep vein thrombosis in the lower or upper extremities.
- Removal of thrombus from dialysis arteriovenous fistulas or grafts.
- Treatment of selected peripheral venous or arterial thrombotic occlusions using catheter-directed aspiration thrombectomy.
- Endovascular clot removal when imaging confirms an accessible peripheral-vessel thrombus or embolus.
Practical Considerations
- The HEL2090 system is a peripheral aspiration thrombectomy device; use requires compatible access sheaths, guidewires, tubing and aspiration equipment according to the manufacturer’s instructions.
- Vessel diameter, clot burden, access route and the required catheter size should be assessed with appropriate imaging before treatment.
- Potential contraindications and precautions include inability to safely access the target vessel, severe vessel tortuosity or stenosis, active bleeding risk, and conditions in which anticoagulation or endovascular intervention is not appropriate.
- MRI safety and conditional-use requirements should be confirmed in the current manufacturer’s labeling before MRI. Do not assume the device or any retained component is MRI safe.
- The system is intended for single-procedure use unless the current labeling states otherwise; it is not an implanted device designed to remain in the body.
Procedures that use this device
Frequently Asked Questions
What is the Helo Max Thrombectomy System used for?
It is used to remove blood clots from peripheral blood vessels by catheter-based aspiration thrombectomy. Clinical applications include selected deep vein thrombosis and thrombosed dialysis access circuits.
Is the Helo Max Thrombectomy System MRI safe?
MRI safety depends on the current manufacturer’s labeling and on whether any component remains in the patient. Confirm the device-specific MRI conditions before scanning.
What sizes does the Helo Max Thrombectomy System come in?
The FDA record identifies the HEL2090 model, but a complete size range should be verified in the current manufacturer’s instructions for use. The appropriate catheter and access system depend on vessel size, clot location and anatomy.
How long does the Helo Max Thrombectomy System last?
It is used during a thrombectomy procedure and is generally not intended to remain implanted. The procedure length varies with clot location, clot burden, access difficulty and whether additional treatment is needed.
How much does the Helo Max Thrombectomy System cost?
Device pricing is not usually listed publicly and varies by hospital, supplier, contract and procedure. Patient costs also depend on insurance coverage, facility fees, physician fees and related imaging or anesthesia.