📋 FDA Reference
Penumbra System Penumbra Jet 7 Reperfusion Catheter with Xtra Flex Technology Penumbra Jet 7max
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 ?
510(k)
Number ?
K202251 ↗
Decision Date ?
August 31, 2020
Product Code ?
NRY Catheter, Thrombus Retriever
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.
FDA-Cleared Indications
- Used for mechanical thrombectomy to remove thrombus from the vascular system.
- Intended for use with an aspiration system during catheter-based clot removal procedures.
- FDA-cleared under product code NRY, Catheter, Thrombus Retriever, 21 CFR 870.1250.
Clinical Applications
- Catheter-based aspiration thrombectomy for removal of intravascular thrombus.
- Mechanical thrombectomy in venous vessels when clot removal is indicated.
- Removal of thrombus from selected peripheral venous circuits by trained specialists using compatible aspiration equipment.
Reported off-label uses
- Use in acute ischemic stroke and other intracranial large-vessel occlusions has been reported for Jet 7-type aspiration catheters, but the specific FDA labeling and clearance should be checked before considering neurovascular use.
- Use for pulmonary embolism thrombectomy has been described in clinical practice for aspiration-catheter systems, but this application may be outside the specific labeling for this device.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Practical Considerations
- The catheter is designed for aspiration thrombectomy and must be connected to a compatible aspiration pump or vacuum system according to the manufacturer's instructions.
- The Xtra Flex design supports navigation through curved or tortuous anatomy, but careful wire and catheter manipulation is required to reduce the risk of vessel injury or catheter damage.
- Available catheter sizes and working dimensions vary by model; confirm the exact Jet 7 or Jet 7MAX specifications, sheath compatibility, and vessel-size requirements before use.
- MRI safety and conditional-use information should be confirmed in the current device instructions for use; do not assume the catheter is safe for MRI while it remains in the patient.
- Contraindications, warnings, and procedural limitations are defined by the current FDA-cleared labeling and manufacturer instructions. Potential complications include bleeding, vascular injury, perforation, dissection, distal embolization, infection, and contrast-related reactions.
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.
Procedures that use this device
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.