đź“‹ FDA Reference
penumbra system reperfusion catheter red 72
Penumbra
Summary: The Penumbra System Reperfusion Catheter RED 72 is a medical device used for mechanical thrombectomy in venous applications. It is primarily used by interventional radiologists and vascular surgeons to remove blood clots.
FDA Clearance Information
Pathway
510K
Number
K211654 ↗
Decision Date
August 16, 2021
Product Code
NRY
Device Class
Class 2
Evidence
15 studies
The Penumbra System Reperfusion Catheter RED 72 was cleared via the FDA 510k pathway on August 16, 2021. Manufactured by Penumbra, it is classified as a Class 2 device under product code NRY.
What It Is
The Penumbra System Reperfusion Catheter RED 72 is a specialized catheter designed for mechanical thrombectomy, a procedure to remove blood clots from veins. It operates by navigating through the vascular system to the site of the clot and using suction to extract the thrombus. This device is crucial in restoring blood flow in cases of venous thrombosis, reducing the risk of complications such as pulmonary embolism.
Clinical Applications
This catheter is commonly used in interventional radiology and vascular surgery settings. It is particularly useful in treating patients with acute venous thromboembolism, including deep vein thrombosis (DVT) and pulmonary embolism (PE). The device is typically utilized in hospital settings where rapid intervention is necessary to prevent further complications from venous blockages.
Indications for Use
The FDA-cleared indications for this device include mechanical thrombectomy for venous thromboembolism. It is intended for patients who have blood clots in their veins that need to be removed to restore normal blood flow.
Practical Considerations
The Penumbra System Reperfusion Catheter RED 72 is compatible with standard guidewires and introducer sheaths. Clinicians should be familiar with catheter navigation techniques and ensure proper imaging guidance during the procedure. The catheter's size and flexibility make it suitable for accessing various venous locations.
Related Literature
The linked study compared systemic thrombolysis with catheter-directed management for acute intermediate-high risk pulmonary embolism. Although the abstract is not available, such studies typically evaluate the efficacy and safety of catheter-based interventions versus systemic drug therapy. Key findings likely include differences in patient outcomes, procedural success rates, and complication rates. Limitations may involve sample size and study design.
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 72 used for?
It is used for mechanical thrombectomy to remove blood clots from veins.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
It is indicated for mechanical thrombectomy in cases of venous thromboembolism, such as deep vein thrombosis and 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.