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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 cleared by the FDA for venous stent applications. It is supported by 7 studies, though specific outcomes and safety data are limited in the provided evidence.
FDA Clearance Information
Pathway
510K
Number
K171612 ↗
Decision Date
June 30, 2017
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Acuity Pro Lead Delivery System was cleared via the FDA 510(k) pathway on June 30, 2017. 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 conditions requiring venous stenting.
Clinical Applications
This device is commonly used in procedures involving venous stenting, particularly in cases where precise lead placement is critical. It is utilized in interventional cardiology and vascular surgery settings.
Evidence Summary
The available literature includes 7 studies, with publication dates ranging from 2016 to 2024. These studies vary in focus, but specific details on outcomes and safety are not extensively covered in the provided abstracts.
Reported Outcomes
Published studies report limited specific outcomes related to the Acuity Pro Lead Delivery System. The evidence provided does not detail efficacy findings directly associated with this device.
Safety Profile
Reported complications include limited safety data, as the provided evidence does not specify adverse events directly linked to the Acuity Pro Lead Delivery System.
Evidence Limitations
The evidence base for the Acuity Pro Lead Delivery System is limited by the lack of detailed outcome and safety data in the provided studies. 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, facilitating lead placement within the venous system.
What outcomes have been reported in clinical studies?
Specific outcomes related to the Acuity Pro Lead Delivery System are not detailed in the provided evidence.
What complications have been reported?
Safety data specific to the Acuity Pro Lead Delivery System is limited in the provided evidence, with no detailed complications reported.
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.