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penumbra system red 68 reperfusion catheter
Penumbra
Summary: The Penumbra System RED 68 Reperfusion Catheter is a medical device used for mechanical thrombectomy in venous systems. It is typically used by interventional radiologists and vascular surgeons to remove blood clots.
FDA Clearance Information
Pathway
510K
Number
K211411 ↗
Decision Date
July 1, 2021
Product Code
NRY
Device Class
Class 2
Evidence
15 studies
The Penumbra System RED 68 Reperfusion Catheter was cleared through the FDA 510(k) pathway on July 1, 2021. Manufactured by Penumbra, it is classified as a Class 2 device under product code NRY.
What It Is
The Penumbra System RED 68 Reperfusion Catheter is a specialized catheter designed for mechanical thrombectomy procedures. It works by navigating through the vascular system to reach and remove blood clots, particularly in venous circulation. The catheter's design allows for effective clot retrieval, helping to restore blood flow and reduce the risk of complications associated with thrombosis.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings for the treatment of venous thromboembolism. It is particularly useful in cases where rapid clot removal is necessary to prevent further complications such as pulmonary embolism. The catheter is used in hospitals and specialized clinics where advanced vascular interventions are performed, often on patients with acute or chronic venous thrombotic conditions.
Indications for Use
The FDA indications for the Penumbra System RED 68 Reperfusion Catheter include its use in mechanical thrombectomy procedures to remove clots from the venous system. This is particularly relevant for patients with conditions like deep vein thrombosis or other forms of venous thromboembolism.
Practical Considerations
The Penumbra System RED 68 is typically compatible with standard guidewires and introducer sheaths used in thrombectomy procedures. Clinicians should be familiar with catheter navigation techniques and consider the vessel size and clot burden when selecting this device for treatment.
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 RED 68 Reperfusion Catheter used for?
It is used for mechanical thrombectomy to remove blood clots from the venous system.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for mechanical thrombectomy in the venous system, particularly for conditions like deep vein thrombosis.
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.