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penumbra system reperfusion catheter red 62
Penumbra
Summary: The Penumbra System Reperfusion Catheter RED 62 is a medical device used in mechanical thrombectomy procedures to remove clots from venous systems. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K203440 ↗
Decision Date
May 20, 2021
Product Code
NRY
Device Class
Class 2
Evidence
15 studies
The Penumbra System Reperfusion Catheter RED 62 was cleared via the FDA 510(k) pathway on May 20, 2021. It is manufactured by Penumbra and classified as a Class 2 device under product code NRY.
What It Is
The Penumbra System Reperfusion Catheter RED 62 is a specialized catheter designed for mechanical thrombectomy procedures. It works by navigating through the vascular system to reach and remove thrombi, or clots, from veins. The device is part of a broader system that may include aspiration pumps and other accessories to facilitate clot removal. Its design allows for efficient navigation and clot retrieval in complex venous anatomy.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings. It is particularly useful in treating patients with acute venous thromboembolism, such as pulmonary embolism or deep vein thrombosis. The catheter is used in hospital settings, often in catheterization labs or interventional suites, where real-time imaging guidance is available. Patients who benefit from this device typically present with significant clot burden that requires mechanical intervention.
Indications for Use
The FDA-cleared indications for the Penumbra System Reperfusion Catheter RED 62 involve the removal of clots from the venous system. It is intended for patients with conditions like pulmonary embolism or deep vein thrombosis, where rapid clot removal is necessary to restore normal blood flow.
Practical Considerations
The Penumbra System Reperfusion Catheter RED 62 is typically available in various sizes to accommodate different patient anatomies. It is compatible with standard guidewires and imaging systems used in interventional procedures. Clinicians should be familiar with the catheter's handling characteristics and ensure proper technique to optimize clot retrieval.
Related Literature
The linked study titled 'Systemic Thrombolysis Versus Catheter Directed Management for Acute Intermediate-high Pulmonary Embolism' explores the efficacy of catheter-directed interventions compared to systemic thrombolysis in treating pulmonary embolism. While specific details and findings are not available, such studies generally aim to determine the safety and effectiveness of localized clot removal techniques. 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 62 used for?
It is used for mechanical thrombectomy to remove clots from the venous system, particularly in cases of pulmonary embolism or deep vein thrombosis.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for the removal of thrombi from the venous system in conditions like pulmonary embolism and 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.