📋 FDA Reference
Penumbra System Ace 68 Reperfusion Catheter
Summary: The Penumbra System ACE 68 Reperfusion Catheter is a medical device used for mechanical thrombectomy in acute ischemic stroke. It is primarily used by interventional radiologists and neurologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K161064 ↗
Decision Date ?
June 12, 2016
Product Code ?
NRY Catheter, Thrombus Retriever
Device Class ?
Class 2
Evidence ?
15 studies
The Penumbra System ACE 68 was cleared through the FDA 510(k) pathway on June 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 a specialized catheter designed for mechanical thrombectomy, a procedure to remove blood clots from the brain's blood vessels in cases of acute ischemic stroke. It works by aspirating the clot through a large-bore catheter, allowing for rapid restoration of blood flow. The device is part of the ADAPT (A Direct Aspiration First Pass Technique) approach, which emphasizes direct aspiration as the first-line treatment.
FDA-Cleared Indications
- Removal of thrombus from the neurovasculature in patients experiencing acute ischemic stroke.
- Use in patients who are candidates for mechanical thrombectomy or thrombus removal according to the device labeling and applicable treatment guidelines.
Clinical Applications
- Endovascular aspiration thrombectomy for acute ischemic stroke caused by an occluding blood clot.
- Direct aspiration as part of an ADAPT-style approach for eligible cerebral large-vessel occlusions.
- Clot aspiration through the intracranial arterial circulation under fluoroscopic guidance.
- Use with compatible aspiration and guide-catheter systems during a hospital-based neurointerventional procedure.
Reported off-label uses
- Aspiration thrombectomy for selected noncerebral arterial thrombi, such as peripheral arterial occlusion, has been described for this device type but is outside the neurovascular indication and should not be assumed to be FDA-cleared.
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.
Practical Considerations
- The ACE 68 is a large-bore catheter; the operator must confirm compatibility with the access sheath, guide catheter, intermediate catheter, and the patient's vascular anatomy.
- The catheter is advanced under fluoroscopic guidance, generally through femoral or radial arterial access, and is used with an aspiration source such as a vacuum pump.
- It is intended for use by clinicians trained in neuroendovascular procedures. Tortuous anatomy, vessel size, vasospasm, dissection, perforation, and bleeding are important procedural considerations.
- MRI safety depends on the exact device and whether it remains in the patient. A temporary catheter used during a procedure is normally removed before MRI; the manufacturer's current labeling should be checked for any retained component or specific MRI conditions.
- It is a single-use catheter and is not intended to remain permanently implanted. Contraindications, warnings, and compatibility requirements should be reviewed in the current instructions for use.
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 even in distal vessel occlusions, expanding the potential applications of the device. However, the study's limitations include its initial experience nature and the need for further research to confirm these findings across larger populations.
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 typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for use in patients with acute ischemic stroke due to large vessel occlusions to restore blood flow by removing the clot.
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.