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penumbra system penumbra jet 7 reperfusion catheter with xtra flex technology penumbra jet 7max
Penumbra
Summary: The Penumbra System Jet 7 Reperfusion Catheter with Xtra Flex Technology is a medical device used for mechanical thrombectomy in venous systems. It is primarily used by interventional radiologists and neurologists to remove clots in patients with stroke.
FDA Clearance Information
Pathway
510K
Number
K202251 ↗
Decision Date
August 31, 2020
Product Code
NRY
Device Class
Class 2
Evidence
15 studies
The Penumbra System Jet 7 Reperfusion Catheter was cleared through the FDA 510(k) pathway on August 31, 2020. Manufactured by Penumbra, it is a Class 2 device under product code NRY.
What It Is
The Penumbra System Jet 7 Reperfusion Catheter with Xtra Flex Technology is designed for aspiration thrombectomy, a procedure to remove blood clots from the vascular system. It utilizes a flexible catheter to navigate the vascular system and apply suction to remove clots. This device is particularly noted for its enhanced flexibility, allowing for improved navigation in challenging vascular anatomy.
Clinical Applications
This device is commonly used in the treatment of acute ischemic stroke, where rapid removal of a thrombus is critical to restoring blood flow to the brain. It is typically employed in hospital settings, particularly in stroke centers, by specialists such as interventional radiologists and neurologists. The device is suitable for patients presenting with large vessel occlusions and is part of the standard care in mechanical thrombectomy procedures.
Indications for Use
The FDA indications for the Penumbra System Jet 7 Reperfusion Catheter include its use in mechanical thrombectomy procedures to remove clots from the venous system. It is intended for patients experiencing conditions such as acute ischemic stroke where clot removal is necessary to restore blood flow.
Practical Considerations
The catheter comes in various sizes to accommodate different patient anatomies and is compatible with standard aspiration pump systems. Clinicians should be aware of the device's flexibility, which aids in navigating tortuous vessels, and ensure proper technique to maximize clot retrieval efficiency.
Related Literature
The linked study compared vacuum pressures and suction forces of different pump systems used in aspiration thrombectomy. It found variations in the performance of different systems, highlighting the importance of selecting an appropriate pump to optimize clot removal. However, the study was limited by its focus on in vitro conditions, which may not fully replicate clinical scenarios.
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 Jet 7 Reperfusion Catheter used for?
It is used for mechanical thrombectomy to remove blood clots in patients with acute ischemic stroke.
What specialties typically use this device?
Interventional radiologists and neurologists primarily use this device in stroke centers and hospitals.
What are the FDA-cleared indications?
The device is indicated for use in mechanical thrombectomy procedures to remove clots from the venous system, particularly 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.