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Penumbra 3d Revascularization Device
Product: Penumbra System — all models and sizes · Where to buy
Summary: The Penumbra 3D Revascularization Device is a mechanical thrombectomy tool used primarily for venous revascularization. Key evidence highlights its use in treating large vessel occlusions.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K162901 ↗
Decision Date ?
April 20, 2017
Product Code ?
NRY Catheter, Thrombus Retriever
Device Class ?
Class 2
Evidence ?
0 studies
The Penumbra 3D Revascularization Device was cleared by the FDA through the 510(k) pathway on April 20, 2017. It is manufactured by Penumbra and classified as a Class 2 device.
What It Is
The Penumbra 3D Revascularization Device is designed for mechanical thrombectomy, specifically targeting venous revascularization. It is intended to aid in the removal of thrombi in patients with large vessel occlusions.
FDA-Cleared Indications
- Mechanical removal of thrombus from blood vessels using catheter-based thrombectomy.
- Use in the vascular anatomy and clinical settings specified in the device's FDA-cleared labeling and instructions for use.
Clinical Applications
- Catheter-based removal of thrombus during selected peripheral venous revascularization procedures.
- Thrombectomy in selected cases of deep vein thrombosis when the treating specialist determines that catheter-based clot removal is appropriate.
- Thrombectomy for selected thrombosed dialysis grafts or fistulas when consistent with the device labeling and procedural plan.
Reported off-label uses
- Use in pulmonary embolism thrombectomy may occur in clinical practice, but the specific indication should be verified against the current FDA labeling and instructions for use.
- Use in neurovascular large-vessel occlusion stroke should not be inferred from the product code alone; a device specifically cleared for that indication should be used when required.
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.
Evidence Summary
The available literature includes 13 studies, encompassing various study types such as RCTs, prospective, and retrospective analyses. These studies span from 2023 to 2024.
Reported Outcomes
Published studies report that the Penumbra 3D Revascularization Device is effective in achieving revascularization in cases of large vessel occlusion. The device has shown promise in improving outcomes in acute ischemic stroke patients, particularly in reducing time to reperfusion.
Safety Profile
Reported complications include challenges in revascularization of organized thrombi and potential delays in onset to reperfusion. Safety data from studies highlight the importance of timely intervention to minimize adverse effects.
Evidence Limitations
The evidence is limited by the relatively small number of studies and the need for more comprehensive data on long-term outcomes. Further research is needed to fully understand the device's efficacy in diverse patient populations.
Practical Considerations
- Device size, catheter compatibility, access route, and target-vessel anatomy must match the instructions for use and the planned thrombectomy system.
- The device is used under fluoroscopic or other appropriate image guidance, commonly through venous or arterial access depending on the labeled procedure.
- Potential complications include bleeding, vascular injury, embolization, vessel perforation, thrombosis, infection, contrast reaction, and complications related to sedation or anesthesia.
- MRI safety is configuration- and labeling-dependent. Confirm the current MR status and conditions in the manufacturer’s instructions before MRI.
- Contraindications, warnings, and limits on clot location, vessel diameter, guidewire or catheter compatibility, and dwell time must be checked in the current instructions for use.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for Penumbra 3D Revascularization Device?
The device is indicated for mechanical thrombectomy in patients with large vessel occlusions, particularly in cases of acute ischemic stroke.
What outcomes have been reported in clinical studies?
Studies have reported effective revascularization and improved outcomes in acute ischemic stroke patients, with a focus on reducing time to reperfusion.
What complications have been reported?
Safety data indicate complications such as challenges in revascularizing organized thrombi and potential delays in onset to reperfusion.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.