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penumbra system reperfusion catheter red 43
Penumbra
Summary: The Penumbra System Reperfusion Catheter RED 43 is a medical device used for mechanical thrombectomy in venous systems, primarily by interventional radiologists and vascular specialists.
FDA Clearance Information
Pathway
510K
Number
K222808 ↗
Decision Date
December 20, 2022
Product Code
NRY
Device Class
Class 2
Evidence
15 studies
The Penumbra System Reperfusion Catheter RED 43 was cleared via the FDA 510k pathway on December 20, 2022. It is manufactured by Penumbra and is classified as a Class 2 device.
What It Is
The Penumbra System Reperfusion Catheter RED 43 is a specialized catheter designed for mechanical thrombectomy procedures. It works by navigating through the vascular system to remove thrombi or blood clots from veins. The device is part of a larger system that includes aspiration and retrieval components, facilitating efficient clot removal.
Clinical Applications
This device is commonly used in the treatment of venous thromboembolism, particularly in cases of acute pulmonary embolism or deep vein thrombosis. It is typically employed in hospital settings by interventional radiologists or vascular surgeons. The device is suitable for patients who require rapid clot removal to restore blood flow and prevent complications.
Indications for Use
The FDA indications suggest that this device is intended for patients with venous thromboembolic conditions, such as pulmonary embolism, where mechanical clot removal is necessary. It is particularly useful in scenarios where traditional thrombolytic therapy is not suitable or has failed.
Practical Considerations
The Penumbra System Reperfusion Catheter RED 43 is available in various sizes to accommodate different vessel diameters. It is compatible with standard guidewires and sheaths used in interventional procedures. Clinicians should be familiar with catheter navigation techniques and the use of aspiration systems.
Related Literature
The linked study compares systemic thrombolysis with catheter-directed management for acute intermediate-high risk pulmonary embolism. While the abstract is not available, such studies typically evaluate the efficacy and safety of catheter-based interventions versus traditional drug therapy. Limitations may include sample size and the lack of long-term outcome data.
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 Reperfusion Catheter RED 43 used for?
It is used for mechanical thrombectomy to remove blood clots from venous systems, such as in pulmonary embolism or deep vein thrombosis.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for mechanical thrombectomy in venous thromboembolic conditions, such as pulmonary embolism.
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.