RoVo Mechanical Thrombectomy System
Product: RoVo Mechanical Thrombectomy System — all models and sizes · Where to buy
FDA Clearance Information
FDA-Cleared Indications
- Removal of thrombi and emboli from peripheral blood vessels.
- Use with aspiration-based mechanical thrombectomy in the peripheral vasculature.
- Use in patients whose vessel size, clot location and anatomy are compatible with the system and its instructions for use.
Clinical Applications
- Mechanical thrombectomy for selected lower-extremity deep vein thrombosis.
- Removal of thrombus from dialysis grafts and fistulas.
- Treatment of selected peripheral venous or arterial thromboembolic occlusions within the labeled vessel-size range.
- Catheter-based clot removal using aspiration during a peripheral vascular intervention.
Reported off-label uses
- Use for pulmonary embolism thrombectomy may be considered off-label unless specifically included in the device's FDA-cleared labeling.
- Use in other vascular beds or vessel sizes outside the labeled indications 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 treating clinician must confirm that the catheter and aspiration components are compatible with the target vessel size, access sheath and guidewire system.
- The procedure generally requires fluoroscopic imaging, vascular access and anticoagulation or other clot-management medication as clinically appropriate.
- Contraindications and warnings include anatomy, access-site problems, bleeding risk, inability to tolerate anticoagulation or contrast, and any restrictions listed in the current instructions for use.
- MRI safety depends on the specific device components and whether any component remains in the patient; the current labeling should be checked before MRI.
- The device is intended for single-use procedures and is not expected to remain implanted after thrombectomy.
Procedures that use this device
Frequently Asked Questions
What is the RoVo Mechanical Thrombectomy System used for?
It is a catheter-based system for removing blood clots from peripheral blood vessels using mechanical thrombectomy and aspiration. Applications may include selected deep vein thrombosis and dialysis-access thrombectomy when they match the FDA-cleared labeling.
Is the RoVo Mechanical Thrombectomy System MRI safe?
MRI safety depends on the specific components and whether any part remains in the body. Check the current FDA labeling and instructions for use before an MRI; the system is generally removed after the procedure.
What sizes does the RoVo Mechanical Thrombectomy System come in?
Available catheter and aspiration sizes, along with compatible access systems, should be confirmed in the manufacturer's current instructions for use. Selection depends on the target vessel diameter, clot burden and access route.
How long does the RoVo Mechanical Thrombectomy System last?
It is a single-use device used during one thrombectomy procedure and is not designed for permanent implantation. How long the procedure takes depends on the clot location, clot burden, access route and patient anatomy.
How much does the RoVo Mechanical Thrombectomy System cost?
The device price and total procedure cost vary by hospital, physician, insurance coverage, facility fees, imaging, medications and length of stay. Patients should request an itemized estimate from the treating facility and insurer.