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selectra 3d lead delivery system 443624-443629 451789-451791 selectra slitter tool 383119 selectra accessory kit 375518
Biotronik
Summary: The Selectra 3D Lead Delivery System by Biotronik is designed for lead placement in cardiac pacing. It is FDA-cleared with evidence supporting its use in conduction system pacing, particularly left bundle branch area pacing.
FDA Clearance Information
Pathway
510K
Number
K240787 ↗
Decision Date
September 12, 2024
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Selectra 3D Lead Delivery System was cleared by the FDA via the 510(k) pathway on September 12, 2024. Manufactured by Biotronik, it is classified as a Class 2 device.
What It Is
The Selectra 3D Lead Delivery System is a medical device used for the delivery of pacing leads in cardiac procedures. It facilitates the placement of leads for conduction system pacing, including left bundle branch area pacing, by providing a stylet-driven mechanism.
Clinical Applications
This device is commonly used in clinical scenarios requiring precise lead placement for cardiac pacing, such as in patients with conduction system disorders. It is particularly useful in performing left bundle branch area pacing and His bundle pacing.
Evidence Summary
The literature includes six studies, ranging from case series to prospective trials, published between 2021 and 2025. These studies explore the feasibility, safety, and efficacy of the Selectra system in various pacing applications.
Reported Outcomes
Published studies report that the Selectra 3D Lead Delivery System is effective in achieving conduction system pacing, particularly left bundle branch area pacing, with favorable pacing thresholds. The device has been shown to be a viable alternative to traditional right ventricular pacing.
Safety Profile
Reported complications include challenges in lead placement due to anatomical variations such as right atriomegaly. However, the studies generally indicate a favorable safety profile with no significant adverse events directly attributed to the device.
Evidence Limitations
Current evidence is limited by the small sample sizes and short follow-up durations in some studies. Further research is needed to assess long-term outcomes and to compare the device's efficacy with other pacing systems.
Frequently Asked Questions
What are the clinical indications for Selectra 3D Lead Delivery System?
The device is indicated for use in conduction system pacing, including left bundle branch area pacing and His bundle pacing.
What outcomes have been reported in clinical studies?
Studies report effective pacing with favorable thresholds and a viable alternative to right ventricular pacing.
What complications have been reported?
Safety data indicate challenges with lead placement in certain anatomies, but no significant adverse events have been 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.