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agills pf delivery system
St. Jude Medical, Cardiac Rhythm Management Divisi
Summary: The agills pf delivery system is a device used in embolization procedures, primarily for pulmonary fibrosis treatment. Key evidence highlights its role in targeted delivery systems.
FDA Clearance Information
Pathway
510K
Number
K111943 ↗
Decision Date
September 29, 2011
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The agills pf delivery system was cleared by the FDA via the 510(k) pathway on September 29, 2011. It is manufactured by St. Jude Medical, Cardiac Rhythm Management Division and is classified as a Class 2 device.
What It Is
The agills pf delivery system is designed for the delivery of therapeutic agents in embolization procedures. It is intended for use in clinical settings to manage conditions like pulmonary fibrosis by facilitating targeted delivery of treatment.
Clinical Applications
This device is commonly used in scenarios requiring precise delivery of embolization agents, particularly in the treatment of pulmonary fibrosis. It is utilized in interventional radiology and pulmonology settings.
Evidence Summary
The available literature includes 10 studies, with a mix of randomized controlled trials and other study types, published between 2024 and 2025. These studies explore novel delivery approaches and therapeutic potentials for pulmonary fibrosis.
Reported Outcomes
Published studies report that the agills pf delivery system shows promise in enhancing the delivery of therapeutic agents for pulmonary fibrosis. The device has been associated with improved targeting of fibrotic tissue and potential amelioration of disease progression.
Safety Profile
Reported complications include challenges in the translation of siRNA therapies and potential adverse reactions related to the delivery system. However, specific safety data from the studies is limited.
Evidence Limitations
The evidence base is limited by the small number of studies and the early stage of research on novel delivery systems. Further research is needed to establish long-term efficacy and safety profiles.
Frequently Asked Questions
What are the clinical indications for agills pf delivery system?
The device is indicated for use in embolization procedures, particularly for conditions like pulmonary fibrosis.
What outcomes have been reported in clinical studies?
Studies have reported potential improvements in targeting fibrotic tissue and disease progression in pulmonary fibrosis.
What complications have been reported?
Safety data is limited, but challenges in siRNA therapy translation and potential adverse reactions have been 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.