📊 Evidence-Based Reference
Cps Locator 3d Delivery Catheter
Centerpoint Systems
Summary: The CPS Locator 3D Delivery Catheter is a medical device used primarily for conduction system pacing. It is FDA 510k cleared and linked to studies exploring its use in left bundle branch area pacing.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K230363 ↗
Decision Date ?
March 9, 2023
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The CPS Locator 3D Delivery Catheter received FDA 510k clearance on March 9, 2023. Manufactured by Centerpoint Systems, it is classified as a Class 2 device under product code DQY.
What It Is
The CPS Locator 3D Delivery Catheter is designed for use in conduction system pacing, specifically targeting the left bundle branch area. It facilitates precise lead placement for optimal pacing outcomes.
FDA-Cleared Indications
- A percutaneous catheter intended to facilitate the delivery or positioning of a pacing lead during a cardiac pacing procedure.
- Use in conduction system pacing procedures, when the treating physician determines that catheter-based lead delivery is appropriate.
Clinical Applications
- Delivery and positioning of pacing leads during conduction system pacing.
- Catheter-assisted access to the region targeted for cardiac pacing lead placement.
- Use during procedures for patients who require permanent cardiac pacing, when the device is selected by the treating physician.
Evidence Summary
The available literature includes two studies published between 2024 and 2025. These studies explore the procedural outcomes and techniques associated with the use of stylet-driven leads in left bundle branch pacing.
Reported Outcomes
Published studies report that the CPS Locator 3D Delivery Catheter is effective in achieving successful lead placement for left bundle branch pacing. The use of stylet-driven leads has shown favorable procedural outcomes compared to traditional methods.
Safety Profile
Reported complications include typical procedural risks associated with lead placement, though specific adverse events are not detailed in the provided studies.
Evidence Limitations
The evidence is limited by the small number of studies and lack of detailed safety outcomes. Further research is needed to assess long-term efficacy and safety in diverse patient populations.
Practical Considerations
- The supplied FDA record does not list catheter dimensions, working length, curve options, guidewire compatibility, or other sizing details; these should be confirmed in the current manufacturer instructions for use.
- The catheter is used with compatible pacing leads and other accessories specified by the manufacturer. Compatibility should be verified before the procedure.
- Use requires fluoroscopic or other appropriate cardiac imaging guidance and an operator familiar with transvenous pacing procedures.
- MRI status applies primarily to the complete implanted pacing system, including the lead and pulse generator, rather than to the delivery catheter after the procedure. Check the labeling for the specific implanted system.
- Potential risks include vascular or cardiac injury, bleeding, infection, arrhythmia, lead dislodgement, and complications related to cardiac device implantation. Patient-specific contraindications and precautions are described in the manufacturer labeling.
Frequently Asked Questions
What are the clinical indications for CPS Locator 3D Delivery Catheter?
The device is indicated for use in conduction system pacing, particularly in left bundle branch area pacing.
What outcomes have been reported in clinical studies?
Studies have reported successful lead placement and favorable procedural outcomes with the use of stylet-driven leads.
What complications have been reported?
Reported complications include general procedural risks, but specific adverse events are not detailed in the studies provided.
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.