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cps locator 3d delivery catheter
Centerpoint Systems
Summary: The CPS Locator 3D Delivery Catheter is a medical device used for venous stent placement. It is primarily used in conduction system pacing procedures. Key evidence highlights its use in left bundle branch area pacing.
FDA Clearance Information
Pathway
510K
Number
K250147 ↗
Decision Date
August 22, 2025
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The CPS Locator 3D Delivery Catheter was cleared through the FDA 510k pathway on August 22, 2025. Manufactured by Centerpoint Systems, it is classified as a Class 2 device.
What It Is
The CPS Locator 3D Delivery Catheter is designed for precise delivery of venous stents, particularly in conduction system pacing. It facilitates the placement of leads in the left bundle branch area, enhancing procedural accuracy.
Clinical Applications
This device is commonly used in procedures involving conduction system pacing, such as left bundle branch area pacing. It is particularly useful in scenarios where precise lead placement is critical for patient outcomes.
Evidence Summary
The literature includes two studies from 2024 and 2025, focusing on the use of stylet-driven leads in conduction system pacing. These studies include randomized controlled trials and other methodologies.
Reported Outcomes
Published studies report that the CPS Locator 3D Delivery Catheter is effective in facilitating left bundle branch pacing with favorable procedural outcomes. The use of stylet-driven leads has shown promising results in terms of acute success rates and procedural efficiency.
Safety Profile
Reported complications include typical procedural risks associated with lead placement, but specific adverse events were not detailed in the provided studies. Overall, the device is considered safe for its intended use.
Evidence Limitations
The evidence is limited by the small number of studies and lack of long-term outcome data. Further research is needed to establish comprehensive safety profiles and efficacy across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for CPS Locator 3D Delivery Catheter?
The device is indicated for use in venous stent placement, particularly in conduction system pacing procedures like left bundle branch area pacing.
What outcomes have been reported in clinical studies?
Studies have reported favorable procedural outcomes and acute success rates with the use of stylet-driven leads for left bundle branch pacing.
What complications have been reported?
Reported complications include general procedural risks, but specific adverse events were not 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.