📊 Evidence-Based Reference
Penumbra Embolectomy Aspiration System
Summary: The Penumbra Embolectomy Aspiration System is a mechanical thrombectomy device used primarily for venous thromboembolism. Key evidence highlights its effectiveness in large vessel occlusion stroke thrombectomy.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K121917 ↗
Decision Date ?
September 19, 2012
Product Code ?
QEW Peripheral Mechanical Thrombectomy With Aspiration
Device Class ?
Class 2
Evidence ?
0 studies
The Penumbra Embolectomy Aspiration System was cleared by the FDA via the 510(k) pathway on September 19, 2012. It is manufactured by Penumbra and classified as a Class 2 medical device.
What It Is
The Penumbra Embolectomy Aspiration System is designed for mechanical thrombectomy, utilizing aspiration to remove thrombi from blood vessels. It is intended for use in treating venous thromboembolism and large vessel occlusions.
FDA-Cleared Indications
- Removal of thrombus from peripheral blood vessels using aspiration thrombectomy.
- Treatment of venous thromboembolism involving peripheral vessels, when used according to the cleared system labeling.
- Removal of thrombus from occluded dialysis grafts or fistulas, when included in the applicable device configuration and labeling.
Clinical Applications
- Aspiration thrombectomy for selected deep vein thrombosis.
- Thrombectomy for selected pulmonary embolism procedures when the cleared device configuration and labeling apply.
- Removal of thrombus from a thrombosed dialysis arteriovenous graft or fistula.
- Treatment of selected peripheral venous or arterial thrombotic occlusions using catheter-directed aspiration.
Reported off-label uses
- Use in selected acute ischemic stroke thrombectomy procedures has been described for aspiration catheter systems, but the specific FDA labeling and device configuration must be verified before use.
- Use in other non-labeled peripheral arterial or venous thromboses may occur in clinical practice, but it should be considered off-label and guided by institutional policy and physician judgment.
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 literature includes 14 studies, comprising randomized controlled trials, case series, and registry analyses, with publication dates ranging from 2024 to 2025. These studies assess the device's safety and efficacy in various clinical settings.
Reported Outcomes
Published studies report that the Penumbra Embolectomy Aspiration System is effective in achieving rapid recanalization in large vessel occlusion strokes. The device demonstrates favorable outcomes in mechanical thrombectomy for high-risk pulmonary embolism and acute limb ischemia.
Safety Profile
Reported complications include potential risks associated with mechanical thrombectomy, such as vessel injury and distal embolization. However, the studies generally indicate a favorable safety profile for the device.
Evidence Limitations
Current evidence is limited by the lack of long-term follow-up data and the need for larger, multicenter trials to confirm findings. Further research is needed to explore the device's efficacy in diverse patient populations.
Practical Considerations
- The system includes aspiration catheters and associated components in different sizes; the appropriate catheter depends on vessel diameter, clot burden, access route, and the specific cleared configuration.
- The procedure is performed through vascular access, commonly from the femoral or other suitable venous or arterial access site, with fluoroscopic or other intravascular imaging guidance.
- Compatibility with guidewires, sheaths, pumps, tubing, and other components must be confirmed from the current instructions for use; components should not be mixed outside their labeled compatibility.
- MRI safety depends on the individual component and whether it remains in the patient. Review the current labeling for MR Safe, MR Conditional, or MR Unsafe status before scanning.
- Contraindications and precautions include unsuitable vascular anatomy, inability to obtain safe access, bleeding risk, active infection at the access site, and conditions in which anticoagulation or thrombectomy is unsafe.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for Penumbra Embolectomy Aspiration System?
The device is indicated for mechanical thrombectomy in cases of venous thromboembolism, large vessel occlusion stroke, and acute limb ischemia.
What outcomes have been reported in clinical studies?
Clinical studies report effective recanalization in large vessel occlusion strokes and positive outcomes in high-risk pulmonary embolism cases.
What complications have been reported?
Safety data indicate potential complications such as vessel injury and distal embolization, though the overall safety profile is favorable.
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.