Vertex Thrombectomy System
Jupiter Endovascular
FDA Clearance Information
FDA-Cleared Indications
- Removal of thrombus or emboli from peripheral blood vessels.
- Removal of thrombus or emboli from synthetic dialysis grafts and native dialysis fistulas.
- Aspiration of thrombus or embolic material during percutaneous thrombectomy procedures.
Clinical Applications
- Percutaneous thrombectomy for selected lower-extremity deep vein thrombosis.
- Removal of clot from dialysis arteriovenous grafts and fistulas.
- Treatment of peripheral venous or arterial thrombus when mechanical aspiration thrombectomy is indicated.
- Clot removal using catheter aspiration under fluoroscopic imaging guidance.
Reported off-label uses
- Use in pulmonary embolism thrombectomy may be off-label unless specifically included in the device's FDA-cleared labeling.
- Use in vascular territories, clot types, or patient populations not listed in the current instructions for use may be off-label.
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 appropriate catheter size, access sheath, and aspiration setup depend on the target vessel, clot burden, and anatomy; users should follow the current instructions for use.
- The procedure is typically performed through percutaneous venous or arterial access with fluoroscopic guidance and may involve moderate sedation or general anesthesia depending on the clinical situation.
- MRI safety and conditions should be confirmed in the current labeling; do not assume the system is MR safe or MR conditional based only on its 510(k) clearance.
- Potential complications include bleeding, vessel injury, perforation, dissection, distal embolization, infection, contrast reaction, and recurrent thrombosis.
- Contraindications, warnings, compatible accessories, and maximum aspiration or dwell parameters must be checked in the manufacturer’s current instructions for use.
Procedures that use this device
Frequently Asked Questions
What is the Vertex Thrombectomy System used for?
It is a catheter-based mechanical thrombectomy and aspiration system for removing thrombus or embolic material from peripheral blood vessels and dialysis vascular access circuits, according to its cleared labeling.
Is the Vertex Thrombectomy System MRI safe?
MRI safety depends on the specific system components and the manufacturer’s current labeling. Check the instructions for use before an MRI examination and do not assume the device is MR safe or MR conditional.
What sizes are available for the Vertex Thrombectomy System?
Available catheter and accessory sizes should be confirmed in the current manufacturer’s product documentation. The appropriate size depends on the target vessel, access route, and amount of thrombus.
How long does the Vertex Thrombectomy System last?
The system is generally intended for use during a single thrombectomy procedure rather than long-term implantation. The catheter and other disposable components are not intended to remain in the body after treatment.
How much does the Vertex Thrombectomy System cost?
The price is not usually listed publicly and may vary by hospital, distributor, contract, and disposable components. A hospital or physician’s billing office can provide procedure-specific cost and insurance information.