đź“Š Evidence-Based Reference
penumbra aspiration system
Penumbra
Summary: The Penumbra aspiration system is a mechanical thrombectomy device used primarily for venous thromboembolism. Key evidence highlights its technical success in endovascular thrombectomy with minimized bleeding risk.
FDA Clearance Information
Pathway
510K
Number
K161506 ↗
Decision Date
September 26, 2016
Product Code
QEW
Device Class
Class 2
Evidence
0 studies
The Penumbra aspiration system was cleared by the FDA via the 510(k) pathway on September 26, 2016. It is manufactured by Penumbra and classified as a Class 2 device.
What It Is
The Penumbra aspiration system is a mechanical thrombectomy device designed to remove thrombi from blood vessels. It operates by aspirating clots through a catheter, providing a minimally invasive option for thrombus removal.
Clinical Applications
Commonly used in scenarios involving high thrombotic burden, such as myocardial infarction and acute mesenteric ischemia. It offers a less invasive alternative to surgical thrombectomy, particularly in high-risk patients.
Evidence Summary
The literature includes 15 studies, comprising case series and reviews, with publication years ranging from 2020 to 2025. These studies explore the device's use in various thrombotic conditions.
Reported Outcomes
Published studies report technically successful endovascular thrombectomy in cases of acute mesenteric ischemia. Outcomes are influenced by factors such as bowel necrosis and sepsis, highlighting the device's efficacy in thrombus removal.
Safety Profile
Reported complications include minimized bleeding risk associated with thrombolytics, as noted in case series involving high-risk patients. No additional safety concerns were highlighted in the provided studies.
Evidence Limitations
The evidence is limited by the small sample sizes and the lack of randomized controlled trials. Further research is needed to establish long-term outcomes and comparative efficacy against other thrombectomy devices.
Frequently Asked Questions
What are the clinical indications for the Penumbra aspiration system?
The device is indicated for mechanical thrombectomy in venous thromboembolism, including conditions like myocardial infarction and acute mesenteric ischemia.
What outcomes have been reported in clinical studies?
Studies report technically successful thrombectomy with outcomes affected by factors such as bowel necrosis and sepsis.
What complications have been reported?
Reported complications include minimized bleeding risk associated with thrombolytics, with no additional safety concerns noted.
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.