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penumbra system separator flex 026 032 041 054 models psf026 psf032 psf041 psf054
Penumbra
Summary: The Penumbra System Separator Flex is a mechanical thrombectomy device used for removing thrombi in venous systems. It is primarily used by interventional radiologists and neurologists in acute care settings.
FDA Clearance Information
Pathway
510K
Number
K100769 ↗
Decision Date
May 21, 2010
Product Code
NRY
Device Class
Class 2
Evidence
15 studies
The Penumbra System Separator Flex was cleared via the 510(k) pathway on May 21, 2010. Manufactured by Penumbra, it is classified as a Class II device under product code NRY.
What It Is
The Penumbra System Separator Flex is a mechanical thrombectomy device designed to remove blood clots from the venous system. It operates by using a flexible catheter to navigate through blood vessels and mechanically disrupt and extract thrombi. This device is particularly useful in acute stroke interventions where rapid restoration of blood flow is critical.
Clinical Applications
This device is commonly used in the treatment of acute ischemic stroke, where rapid clot removal can significantly improve patient outcomes. It is typically employed in hospital settings, particularly in interventional radiology and neurology departments. The device is suitable for adult patients experiencing venous thromboembolism or other conditions leading to vascular occlusion.
Indications for Use
The FDA indications suggest that this device is intended for mechanical thrombectomy in patients with venous thromboembolism. It is used to remove clots that can cause blockages in blood vessels, particularly in cases of acute ischemic stroke.
Practical Considerations
The device comes in multiple sizes (026, 032, 041, 054), allowing for compatibility with various vessel diameters. Clinicians should be trained in endovascular techniques and consider vessel size and clot location when selecting the appropriate model.
Related Literature
The linked study, 'Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke 3,' likely investigates the efficacy of endovascular therapy in stroke patients. Although the abstract is unavailable, such studies typically assess outcomes like reperfusion rates and functional recovery. Limitations may include sample size and study design specifics.
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 Separator Flex used for?
It is used for mechanical thrombectomy to remove blood clots in the venous system, particularly in acute ischemic stroke.
What specialties typically use this device?
Interventional radiologists and neurologists commonly use this device in acute care settings.
What are the FDA-cleared indications?
The device is indicated for mechanical thrombectomy in patients with venous thromboembolism, especially in cases of acute ischemic stroke.
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.