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penumbra 3d revascularization device
Penumbra
Summary: The Penumbra 3D Revascularization Device is a mechanical thrombectomy tool used primarily for venous revascularization. Key evidence highlights its use in treating large vessel occlusions.
FDA Clearance Information
Pathway
510K
Number
K162901 ↗
Decision Date
April 20, 2017
Product Code
NRY
Device Class
Class 2
Evidence
0 studies
The Penumbra 3D Revascularization Device was cleared by the FDA through the 510(k) pathway on April 20, 2017. It is manufactured by Penumbra and classified as a Class 2 device.
What It Is
The Penumbra 3D Revascularization Device is designed for mechanical thrombectomy, specifically targeting venous revascularization. It is intended to aid in the removal of thrombi in patients with large vessel occlusions.
Clinical Applications
This device is commonly used in clinical scenarios involving acute ischemic stroke due to large vessel occlusion. It is particularly useful in cases where rapid revascularization is critical.
Evidence Summary
The available literature includes 13 studies, encompassing various study types such as RCTs, prospective, and retrospective analyses. These studies span from 2023 to 2024.
Reported Outcomes
Published studies report that the Penumbra 3D Revascularization Device is effective in achieving revascularization in cases of large vessel occlusion. The device has shown promise in improving outcomes in acute ischemic stroke patients, particularly in reducing time to reperfusion.
Safety Profile
Reported complications include challenges in revascularization of organized thrombi and potential delays in onset to reperfusion. Safety data from studies highlight the importance of timely intervention to minimize adverse effects.
Evidence Limitations
The evidence is limited by the relatively small number of studies and the need for more comprehensive data on long-term outcomes. Further research is needed to fully understand the device's efficacy in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Penumbra 3D Revascularization Device?
The device is indicated for mechanical thrombectomy in patients with large vessel occlusions, particularly in cases of acute ischemic stroke.
What outcomes have been reported in clinical studies?
Studies have reported effective revascularization and improved outcomes in acute ischemic stroke patients, with a focus on reducing time to reperfusion.
What complications have been reported?
Safety data indicate complications such as challenges in revascularizing organized thrombi and potential delays in onset to reperfusion.
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.