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penumbra system 110 aspiration tubing
Penumbra
Summary: The Penumbra System 110 Aspiration Tubing is a medical device used in mechanical thrombectomy procedures, primarily for venous applications. It is utilized by interventional radiologists and neurologists to remove blood clots.
FDA Clearance Information
Pathway
510K
Number
K151623 ↗
Decision Date
August 6, 2015
Product Code
NRY
Device Class
Class 2
Evidence
15 studies
The Penumbra System 110 Aspiration Tubing was cleared via the FDA 510(k) pathway on August 6, 2015. Manufactured by Penumbra, it is classified as a Class 2 device under product code NRY.
What It Is
The Penumbra System 110 Aspiration Tubing is part of a mechanical thrombectomy system designed to remove thrombi or blood clots from the vascular system. It works by providing a conduit for aspiration, allowing for the removal of clots through suction. This device is essential in procedures aiming to restore blood flow in cases of acute ischemic stroke or other thrombotic events.
Clinical Applications
This device is commonly used in interventional radiology and neurology settings, particularly in the treatment of acute ischemic stroke where rapid clot removal is critical. It is employed in hospitals with specialized stroke centers and is suitable for adult patients experiencing venous thrombotic events. The tubing is part of a larger system that facilitates the removal of clots from the brain's vasculature.
Indications for Use
The FDA-cleared indications for the Penumbra System 110 Aspiration Tubing include its use in mechanical thrombectomy procedures to treat patients with venous thrombotic conditions. It is specifically indicated for the removal of clots to restore blood flow in patients suffering from acute ischemic stroke.
Practical Considerations
The Penumbra System 110 Aspiration Tubing is typically compatible with other components of the Penumbra System. Clinicians should ensure proper sizing and compatibility with the patient's vascular anatomy. Technique considerations include ensuring adequate suction and maintaining catheter stability during the procedure.
Related Literature
The linked study, 'Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke 3,' likely investigates the efficacy of endovascular therapy in stroke patients, although specific details are unavailable. The study may focus on imaging techniques to evaluate patient suitability for thrombectomy. Limitations include the lack of available abstract and year, which restricts detailed analysis.
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 Penumbra System 110 Aspiration Tubing used for?
It is used for mechanical thrombectomy to remove blood clots in patients with venous thrombotic conditions, such as acute ischemic stroke.
What specialties typically use this device?
Interventional radiologists and neurologists commonly use this device in stroke centers and hospitals.
What are the FDA-cleared indications?
It is indicated for mechanical thrombectomy procedures to treat venous thrombotic conditions, particularly in acute ischemic stroke patients.
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.