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silvertorque cerebral catheter
Surgimed
Summary: The Silvertorque cerebral catheter, manufactured by Surgimed, is a device used in cerebral interventions. It was FDA cleared via the 510(k) pathway in 1984. Key evidence includes studies on catheter occlusion and cerebral embolic protection.
FDA Clearance Information
Pathway
510K
Number
K840762 ↗
Decision Date
July 13, 1984
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Silvertorque cerebral catheter was cleared by the FDA through the 510(k) pathway on July 13, 1984. It is manufactured by Surgimed and classified as a Class 2 device under product code DQY.
What It Is
The Silvertorque cerebral catheter is designed for use in cerebral interventions, particularly involving venous stents. It facilitates the delivery of therapeutic agents or devices to the cerebral vasculature.
Clinical Applications
Commonly used in procedures requiring cerebral access, such as embolic protection during transcatheter interventions. It is also utilized in scenarios involving cerebral hypoperfusion management.
Evidence Summary
The literature includes 10 studies, with a mix of RCTs, prospective, and retrospective designs. The studies span from 2017 to 2023, focusing on catheter occlusion and cerebral protection.
Reported Outcomes
Published studies report varied outcomes, including the effectiveness of embolic protection during transcatheter heart interventions and the impact of catheter use on cerebral microcirculation. However, specific efficacy metrics are not detailed in the provided abstracts.
Safety Profile
Reported complications include potential catheter occlusion and issues related to cerebral embolic protection. The evidence does not provide detailed safety metrics or adverse event rates.
Evidence Limitations
The evidence lacks comprehensive outcome data and detailed safety profiles. Further research is needed to establish consistent models for studying catheter occlusion and to evaluate long-term safety and efficacy.
Frequently Asked Questions
What are the clinical indications for Silvertorque cerebral catheter?
The clinical indications are detailed in the FDA documentation, primarily involving cerebral interventions and venous stenting.
What outcomes have been reported in clinical studies?
Studies report outcomes related to embolic protection and catheter occlusion, but specific efficacy data is limited.
What complications have been reported?
Safety data indicates potential for catheter occlusion and complications related to cerebral embolic protection.
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.