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penumbra balloon guide catheter model 7 5f
Penumbra
Summary: The Penumbra Balloon Guide Catheter Model 7 5F is a device used primarily in mechanical thrombectomy procedures. Key evidence highlights its role in improving outcomes in acute ischemic stroke treatment.
FDA Clearance Information
Pathway
510K
Number
K053491 ↗
Decision Date
April 27, 2006
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Penumbra Balloon Guide Catheter Model 7 5F was cleared by the FDA through the 510(k) pathway on April 27, 2006. It is manufactured by Penumbra and classified as a Class 2 device.
What It Is
The Penumbra Balloon Guide Catheter Model 7 5F is designed to assist in the delivery of interventional devices during mechanical thrombectomy procedures. It is used to facilitate the removal of thrombi in patients with acute ischemic stroke.
Clinical Applications
This device is commonly used in endovascular procedures for patients experiencing acute ischemic stroke due to large vessel occlusion. It aids in the navigation and deployment of stent retrievers or aspiration catheters.
Evidence Summary
The available literature includes 10 studies, primarily retrospective and real-world analyses, conducted between 2025. These studies focus on the efficacy and safety of mechanical thrombectomy devices.
Reported Outcomes
Published studies report that the use of mechanical thrombectomy devices, including the Penumbra Balloon Guide Catheter, is associated with improved functional outcomes in acute ischemic stroke patients. Successful reperfusion and reduced disability at 90 days are common findings.
Safety Profile
Reported complications include intracranial hemorrhage, although it was not significantly associated with the use of the device in the studies reviewed. Overall, the safety profile is consistent with other devices used in similar procedures.
Evidence Limitations
The evidence is limited by the retrospective nature of many studies and the lack of randomized controlled trials. Further research is needed to establish long-term outcomes and to compare the efficacy of different thrombectomy devices.
Frequently Asked Questions
What are the clinical indications for Penumbra Balloon Guide Catheter Model 7 5F?
The device is indicated for use in mechanical thrombectomy procedures for the treatment of acute ischemic stroke due to large vessel occlusion.
What outcomes have been reported in clinical studies?
Studies have reported improved functional outcomes and successful reperfusion in patients treated with mechanical thrombectomy devices.
What complications have been reported?
Safety data indicate that intracranial hemorrhage is a potential complication, though not significantly associated with the device in reviewed studies.
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.