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coronary sinus visualization system model csvs5508
Acumen Medical
Summary: The coronary sinus visualization system CSVS5508 by Acumen Medical is designed for visualizing the coronary sinus during interventions. It is FDA 510k cleared and supported by 15 studies, highlighting its role in venous-stent procedures.
FDA Clearance Information
Pathway
510K
Number
K042381 ↗
Decision Date
December 28, 2004
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The coronary sinus visualization system CSVS5508 was cleared through the FDA 510k pathway on December 28, 2004. Manufactured by Acumen Medical, it is classified as a Class 2 device under product code DQY.
What It Is
The CSVS5508 is a coronary sinus visualization system that aids in the visualization of the coronary sinus during cardiac interventions. It is intended for use in procedures involving venous stents, providing clinicians with enhanced imaging capabilities.
Clinical Applications
This device is commonly used in procedures requiring detailed visualization of the coronary sinus, such as the placement of venous stents. It is particularly useful in electrophysiological studies and interventions where precise imaging is crucial.
Evidence Summary
The available literature includes 15 studies, encompassing various study types such as RCTs, case series, and other observational studies. The research spans from 2008 to 2021, providing a comprehensive overview of the device's clinical applications.
Reported Outcomes
Published studies report that the CSVS5508 system enhances visualization of the coronary sinus, facilitating successful venous stent placement. The device has been associated with improved procedural accuracy and outcomes in electrophysiological interventions.
Safety Profile
Reported complications include potential imaging artifacts and procedural challenges associated with device use. However, no significant adverse events directly attributable to the device have been documented in the available literature.
Evidence Limitations
The evidence is limited by the small sample sizes and the lack of long-term outcome data. Further research is needed to establish the device's efficacy in diverse patient populations and to explore potential improvements in imaging technology.
Frequently Asked Questions
What are the clinical indications for the coronary sinus visualization system?
The device is indicated for use in procedures requiring visualization of the coronary sinus, particularly in the context of venous stent placement.
What outcomes have been reported in clinical studies?
Studies have reported enhanced visualization and procedural success in venous stent placements and electrophysiological interventions.
What complications have been reported?
Reported complications include imaging artifacts and procedural challenges, with no significant adverse events directly linked to the device.
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.