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acuity pro lead delivery system
Boston Scientific
Summary: The Acuity Pro Lead Delivery System by Boston Scientific is a Class 2 medical device used in venous stenting. It was FDA-cleared via the 510k pathway in 2014. Current evidence includes 7 studies, though specific outcomes and safety data are limited.
FDA Clearance Information
Pathway
510K
Number
K132914 ↗
Decision Date
April 3, 2014
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Acuity Pro Lead Delivery System was cleared by the FDA via the 510k pathway on April 3, 2014. Manufactured by Boston Scientific, it is classified as a Class 2 device under product code DQY.
What It Is
The Acuity Pro Lead Delivery System is designed for the delivery of leads in venous stenting procedures. It facilitates the placement of leads within the venous system, aiding in the management of various cardiovascular conditions.
Clinical Applications
Commonly used in procedures requiring venous stenting, the device is integral in the placement of leads for cardiac resynchronization therapy and other cardiovascular interventions.
Evidence Summary
The available literature includes 7 studies, though the specific types and outcomes are not detailed. The studies span various years, with some lacking publication dates, indicating a need for more comprehensive and recent data.
Reported Outcomes
Published studies report limited specific outcomes related to the Acuity Pro Lead Delivery System. The evidence provided does not detail efficacy findings, highlighting a gap in the available literature.
Safety Profile
Reported complications include limited safety data from the studies provided. The absence of detailed adverse event reporting suggests a need for more focused safety evaluations.
Evidence Limitations
The evidence base for the Acuity Pro Lead Delivery System is limited, with gaps in detailed outcomes and safety data. Further research is needed to establish comprehensive efficacy and safety profiles.
Frequently Asked Questions
What are the clinical indications for Acuity Pro Lead Delivery System?
The device is indicated for use in venous stenting procedures, particularly in the placement of leads for cardiac resynchronization therapy.
What outcomes have been reported in clinical studies?
Specific findings from the evidence are limited, with no detailed efficacy outcomes reported in the studies provided.
What complications have been reported?
Safety data from the evidence is sparse, with no specific complications detailed in the available 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.