đź“Š Evidence-Based Reference
penumbra system
Penumbra
Summary: The Penumbra System is a mechanical thrombectomy device used primarily for acute ischemic stroke. Key evidence highlights its efficacy in achieving revascularization with a first-pass effect.
FDA Clearance Information
Pathway
510K
Number
K180008 ↗
Decision Date
June 20, 2018
Product Code
NRY
Device Class
Class 2
Evidence
15 studies
The Penumbra System was cleared by the FDA via the 510(k) pathway on June 20, 2018. It is manufactured by Penumbra and classified as a Class 2 device.
What It Is
The Penumbra System is a mechanical thrombectomy device designed to remove thrombi from blood vessels. It is primarily used in the treatment of acute ischemic stroke to restore blood flow by aspirating the clot.
Clinical Applications
Commonly used in acute ischemic stroke cases, the Penumbra System is applied in scenarios where rapid revascularization is critical. It is also used in cases of mesenteric ischemia due to its ability to effectively remove thrombi.
Evidence Summary
The literature includes 15 studies, comprising RCTs, prospective, and retrospective analyses, spanning from 2020 to 2026. These studies evaluate the device's efficacy and safety in real-world and controlled settings.
Reported Outcomes
Published studies report that the Penumbra System is effective in achieving revascularization in acute ischemic stroke, with a notable first-pass effect. The COMPLETE registry highlights its efficacy in routine practice, while other studies demonstrate its utility in late-onset treatment scenarios.
Safety Profile
Reported complications include risks associated with endovascular procedures, such as vessel perforation and distal embolization. However, the studies generally support a favorable safety profile for the device.
Evidence Limitations
Current evidence is limited by the variability in study designs and patient populations. Further research is needed to establish long-term outcomes and to compare the device's efficacy against other thrombectomy systems.
Linked Studies (15)
PubMed • 2026
First-Pass Effect With Aspiration Thrombectomy With the Penumbra System in Patients With Acute Ischemic Stroke: A Core Laboratory-Adjudicated Subset Analysis of the COMPLETE Registry.
Stroke (Hoboken, N.J.)
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2023
Aspiration thrombectomy with the Penumbra System for patients with stroke and late onset to treatment: a subset analysis of the COMPLETE registry.
Frontiers in neurology
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2022
Endovascular Treatment of Acute Ischemic Stroke With the Penumbra System in Routine Practice: COMPLETE Registry Results.
Stroke
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2019
Efficacy of a coaxial system with a compliant balloon catheter for navigation of the Penumbra reperfusion catheter in tortuous arteries: technique and case experience.
Journal of neurosurgery
View Source →
PubMed • 2018
Unilateral Acute Renal Artery Embolism: An Index Case of Successful Mechanical Aspiration Thrombectomy With Use of Penumbra Indigo Aspiration System and a Review of the Literature.
Vascular and endovascular surgery
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2017
Efficiency of the Penumbra 5MAX ACE Reperfusion Catheter in Acute Ischemic Stroke Patients.
Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2015
Mechanical thrombectomy with the penumbra 3D separator and lesional aspiration: technical feasibility and clinical outcome.
Clinical neuroradiology
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2015
Cerebral Venous Sinus Thrombosis: Successful Treatment of Two Patients Using the Penumbra System and Review of Endovascular Approaches.
The neuroradiology journal
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2012
Rescue forced-suction thrombectomy using the reperfusion catheter of the Penumbra System for thromboembolism during coil embolization of ruptured cerebral aneurysms.
Neurosurgery
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2012
The Penumbra system for mechanical thrombectomy in endovascular acute ischemic stroke therapy.
Neurology
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2011
Direct thrombus retrieval using the reperfusion catheter of the penumbra system: forced-suction thrombectomy in acute ischemic stroke.
AJNR. American journal of neuroradiology
RCT|prospective|retrospective|case Series|other View Source →
ClinicalTrials.gov
COMPLETE: International Acute Ischemic Stroke Registry With the Penumbra System Aspiration Including the 3D Revascularization Device
View Source →
ClinicalTrials.gov
A Randomized, Concurrent Controlled Trial to Assess the Safety and Effectiveness of the Separator 3D as a Component of the Penumbra System in the Revascularization of Large Vessel Occlusion in Acute Ischemic Stroke
View Source →
ClinicalTrials.gov
European Registry on the ACE Reperfusion Catheters and the Penumbra System in the Treatment of Acute Ischemic Stroke
View Source →Frequently Asked Questions
What are the clinical indications for Penumbra System?
The Penumbra System is indicated for mechanical thrombectomy in acute ischemic stroke and has been used in cases of mesenteric ischemia.
What outcomes have been reported in clinical studies?
Studies report successful revascularization with a high first-pass effect rate, particularly in acute ischemic stroke cases.
What complications have been reported?
Safety data indicate potential complications such as vessel perforation and distal embolization, though these are relatively infrequent.
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.