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penumbra system ace
Penumbra
Summary: The Penumbra System ACE is a mechanical thrombectomy device used primarily for venous thrombectomy. Key evidence highlights its role in improving reperfusion outcomes.
FDA Clearance Information
Pathway
510K
Number
K142458 ↗
Decision Date
May 22, 2015
Product Code
NRY
Device Class
Class 2
Evidence
15 studies
The Penumbra System ACE was cleared by the FDA via the 510(k) pathway on May 22, 2015. It is manufactured by Penumbra and classified as a Class 2 device.
What It Is
The Penumbra System ACE is a mechanical thrombectomy device designed for the removal of thrombi in venous systems. It operates by aspirating clots to restore blood flow in occluded vessels.
Clinical Applications
Commonly used in the treatment of acute ischemic stroke and other conditions involving venous thrombosis, the device is applied in scenarios requiring rapid restoration of blood flow.
Evidence Summary
The literature includes 13 studies, encompassing RCTs, prospective, and retrospective analyses, with a focus on mechanical thrombectomy. The studies span from 2020 to 2023.
Reported Outcomes
Published studies report that the Penumbra System ACE is effective in achieving reperfusion in cases of acute ischemic stroke. One study noted a 32.8% prevalence of infarcts in new territory, impacting functional independence.
Safety Profile
Reported complications include the occurrence of infarcts in new territory, which were associated with lower rates of functional independence. Safety data on intra-arterial fibrinolytics as adjuncts to thrombectomy are sparse.
Evidence Limitations
Evidence gaps include limited data on long-term outcomes and the safety of adjunctive therapies. Further research is needed to explore the full efficacy and safety profile of the device.
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 ACE?
The device is indicated for mechanical thrombectomy in venous systems, particularly in acute ischemic stroke.
What outcomes have been reported in clinical studies?
Studies report effective reperfusion and a 32.8% prevalence of infarcts in new territory, affecting functional independence.
What complications have been reported?
Reported complications include infarcts in new territory, with associated impacts on functional independence.
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.