📊 Evidence-Based Reference
Penumbra System Ace 64 and Ace 68 Reperfusion Catheters
Summary: The Penumbra System ACE 64 and ACE 68 are reperfusion catheters used in mechanical thrombectomy for venous applications. Key evidence highlights their role in improving reperfusion outcomes.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K152541 ↗
Decision Date ?
January 13, 2016
Product Code ?
NRY Catheter, Thrombus Retriever
Device Class ?
Class 2
Evidence ?
15 studies
The Penumbra System ACE 64 and ACE 68 were cleared by the FDA via the 510(k) pathway on January 13, 2016. Manufactured by Penumbra, these devices are classified as Class 2 under product code NRY.
What It Is
The Penumbra System ACE 64 and ACE 68 are reperfusion catheters designed for mechanical thrombectomy procedures. They are used to remove thrombi from blood vessels, particularly in venous applications, to restore blood flow.
FDA-Cleared Indications
- Intended for use in the neurovasculature to restore blood flow by removing thrombus.
- Used with compatible aspiration and guide-catheter systems during mechanical thrombectomy procedures.
- The FDA clearance applies to adult patients with thrombotic or embolic occlusion of large vessels in the neurovasculature.
Clinical Applications
- Aspiration thrombectomy for acute ischemic stroke caused by large-vessel occlusion.
- Removal of thrombus or embolus from intracranial arteries during neurointerventional treatment.
- Revascularization of the neurovasculature when rapid restoration of cerebral blood flow is needed.
Reported off-label uses
- Aspiration thrombectomy in selected peripheral venous or arterial vessels, including deep-vein thrombosis or pulmonary embolism, may be reported in clinical practice but is outside the stated neurovascular indication.
- Use in dialysis-access thrombectomy may occur with catheter systems of this type, but should not be assumed to be covered by this device's FDA indication.
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 two studies, one from 2021 and another from 2024, focusing on the long-term effects and adjunctive use of fibrinolytics in mechanical thrombectomy. Study types include systematic reviews and meta-analyses.
Reported Outcomes
Published studies report that mechanical thrombectomy using the Penumbra System ACE catheters can improve long-term outcomes in stroke patients, particularly those with large ischemic cores. The adjunctive use of intra-arterial fibrinolytics may enhance reperfusion efficacy.
Safety Profile
Reported complications include sparse data on the safety of adjunctive intra-arterial fibrinolytics. The studies highlight the need for further investigation into potential adverse events associated with these adjunctive therapies.
Evidence Limitations
The evidence is limited by the scarcity of data on long-term outcomes and safety of adjunctive therapies. Further research is needed to establish comprehensive safety profiles and efficacy in diverse patient populations.
Practical Considerations
- ACE 64 and ACE 68 are large-bore aspiration catheters; the number refers approximately to the catheter's internal diameter in thousandths of an inch.
- The catheter must be used with compatible guide catheters, aspiration tubing, and a vacuum or aspiration pump according to the manufacturer's instructions.
- Access is commonly obtained through the femoral or radial artery for neurovascular procedures, with fluoroscopic or angiographic guidance.
- The device is intended for single use and should not be resterilized or reused.
- MRI safety and conditional-use details depend on the exact device labeling and the complete procedure setup; verify current manufacturer instructions before MRI.
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 64 and ACE 68?
The devices are indicated for mechanical thrombectomy in venous applications, particularly in acute ischemic stroke with large vessel occlusions.
What outcomes have been reported in clinical studies?
Studies report improved long-term outcomes in stroke patients and enhanced reperfusion with adjunctive intra-arterial fibrinolytics.
What complications have been reported?
Safety data is limited, but there is a need for further research into potential adverse events associated with adjunctive intra-arterial fibrinolytics.
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.