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penumbra system modified 110 aspiration tubing
Penumbra
Summary: The Penumbra System Modified 110 Aspiration Tubing is a medical device used for mechanical thrombectomy in venous applications. It is FDA-cleared and supported by clinical studies, though specific outcomes and safety data are not detailed in the available evidence.
FDA Clearance Information
Pathway
510K
Number
K182522 ↗
Decision Date
October 12, 2018
Product Code
NRY
Device Class
Class 2
Evidence
15 studies
The Penumbra System Modified 110 Aspiration Tubing was cleared by the FDA via the 510(k) pathway on October 12, 2018. It is manufactured by Penumbra and classified as a Class 2 device under product code NRY.
What It Is
The Penumbra System Modified 110 Aspiration Tubing is designed for use in mechanical thrombectomy procedures, specifically targeting venous thromboembolic events. It functions by aspirating thrombi from the vasculature to restore blood flow.
Clinical Applications
This device is commonly used in clinical settings for the removal of thrombi in patients experiencing venous thromboembolic events. It is particularly relevant in cases where rapid recanalization is necessary to prevent further complications.
Evidence Summary
The available literature includes three studies registered on ClinicalTrials.gov, focusing on mechanical thrombectomy and related outcomes. The studies do not provide specific details on sample sizes or publication years.
Reported Outcomes
Published studies report the use of the Penumbra System in mechanical thrombectomy procedures, though specific efficacy outcomes are not detailed in the provided evidence. Further research is needed to quantify its effectiveness in clinical practice.
Safety Profile
Reported complications include general risks associated with mechanical thrombectomy, but specific adverse events related to the Penumbra System Modified 110 Aspiration Tubing are not detailed in the available evidence.
Evidence Limitations
The evidence lacks specific data on clinical outcomes and safety profiles, highlighting a need for further research to establish comprehensive efficacy and safety metrics. Study limitations include unspecified sample sizes and outcomes.
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 are the clinical indications for Penumbra System Modified 110 Aspiration Tubing?
The device is indicated for mechanical thrombectomy in venous thromboembolic events, aiming to restore blood flow by aspirating thrombi.
What outcomes have been reported in clinical studies?
Specific outcomes are not detailed in the available evidence, indicating a need for further research to establish efficacy.
What complications have been reported?
Safety data specific to this device is limited, with general risks associated with mechanical thrombectomy noted but not detailed.
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.