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Penumbra System Ace 68 Reperfusion Catheter
Product: Penumbra System — all models and sizes · Where to buy
Summary: The Penumbra System ACE 68 Reperfusion Catheter is a medical device used for mechanical thrombectomy in patients with acute ischemic stroke. It is primarily used by interventional radiologists and neurologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K161640 ↗
Decision Date ?
July 12, 2016
Product Code ?
NRY Catheter, Thrombus Retriever
Device Class ?
Class 2
Evidence ?
15 studies
The Penumbra System ACE 68 Reperfusion Catheter was cleared through the FDA 510(k) pathway on July 12, 2016. It is manufactured by Penumbra and classified as a Class 2 device under product code NRY.
What It Is
The Penumbra System ACE 68 Reperfusion Catheter is designed for mechanical thrombectomy, a procedure to remove blood clots from the brain's blood vessels in patients experiencing an acute ischemic stroke. The catheter is inserted into the vascular system and navigated to the site of the clot, where it helps restore blood flow by aspirating the clot. This device is part of the Penumbra System, which includes various components for comprehensive stroke management.
FDA-Cleared Indications
- For use in the revascularization of patients with acute ischemic stroke caused by large-vessel occlusion.
- Intended to remove thrombus from blood vessels using aspiration-based mechanical thrombectomy.
Clinical Applications
- Aspiration thrombectomy for selected patients with acute ischemic stroke and a large-vessel occlusion.
- Endovascular removal of thrombus from intracranial cerebral arteries during stroke intervention.
- Use in a neurointerventional or interventional radiology suite with fluoroscopic guidance and an aspiration system.
Practical Considerations
- The catheter is intended for use with compatible Penumbra aspiration-system components and appropriate guide or access catheters; clinicians must confirm device compatibility before use.
- It is navigated through the arterial system under fluoroscopic guidance, typically through femoral or radial arterial access, depending on the operator's approach.
- The ACE 68 is a specific catheter size; the available catheter dimensions, inner diameter, working length and compatibility should be verified in the current manufacturer instructions for use.
- Use requires trained neurointerventional or interventional radiology personnel familiar with cerebral angiography, aspiration thrombectomy and management of stroke-related complications.
- MRI safety and conditional-use information should be checked in the current manufacturer labeling. The catheter is generally used during an acute procedure and is not intended to remain implanted.
Related Literature
The linked study explored the use of the Penumbra ACE and 3MAX reperfusion system in treating patients with symptomatic M2 and M3 occlusions in acute ischemic stroke. The study found that mechanical thrombectomy could be beneficial in these distal vessel occlusions, expanding the potential use of thrombectomy beyond large vessel occlusions. However, the study was limited by its initial experience and the need for further research to confirm these findings.
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 is the Penumbra System ACE 68 Reperfusion Catheter used for?
It is used for mechanical thrombectomy to remove clots in patients with acute ischemic stroke.
What specialties typically use this device?
Interventional radiologists and neurologists specializing in stroke management typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in patients with acute ischemic stroke due to large vessel occlusions to help remove clots and restore blood flow.
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.