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selectra lead implantation system
Biotronik
Summary: The Selectra Lead Implantation System by Biotronik is used for conduction system pacing, particularly left bundle branch area pacing (LBBAP). Key evidence highlights its effectiveness and safety in mimicking natural cardiac conduction.
FDA Clearance Information
Pathway
510K
Number
K222037 ↗
Decision Date
July 19, 2022
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Selectra Lead Implantation System was cleared by the FDA via the 510(k) pathway on July 19, 2022. It is manufactured by Biotronik and classified as a Class 2 device under product code DQY.
What It Is
The Selectra Lead Implantation System is designed for conduction system pacing, specifically targeting the left bundle branch area. It aims to provide a more physiological pacing alternative compared to traditional right ventricular pacing.
Clinical Applications
This device is commonly used in scenarios requiring cardiac pacing, particularly in patients where traditional pacing methods may increase the risk of heart failure or atrial fibrillation. It is utilized in both His bundle pacing and left bundle branch area pacing.
Evidence Summary
The literature includes a mix of RCTs, prospective, retrospective, and case series studies, with a total of 9 studies published between 2023 and 2025. These studies explore the efficacy and safety of the Selectra system in various clinical settings.
Reported Outcomes
Published studies report that the Selectra Lead Implantation System is effective in achieving stable pacing thresholds and mimicking natural cardiac conduction. Left bundle branch area pacing using this system has shown favorable outcomes in terms of pacing stability and reduced risk of heart failure.
Safety Profile
Reported complications include typical risks associated with lead implantation, such as lead dislodgement and infection. However, the studies indicate that the Selectra system maintains a safety profile comparable to other pacing systems.
Evidence Limitations
The current evidence is limited by the relatively short follow-up periods and small sample sizes in some studies. Further research is needed to assess long-term outcomes and compare the system's efficacy against other pacing modalities.
Frequently Asked Questions
What are the clinical indications for Selectra Lead Implantation System?
The system is indicated for conduction system pacing, particularly in patients requiring left bundle branch area pacing to mimic natural cardiac conduction.
What outcomes have been reported in clinical studies?
Studies have reported effective pacing thresholds and stability, with reduced risks of heart failure and atrial fibrillation compared to traditional pacing methods.
What complications have been reported?
Safety data indicate risks such as lead dislodgement and infection, but overall, the system has a safety profile similar to other pacing systems.
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.