LBBAP Manufacturers (Non‑Medtronic)
A quick reference to manufacturers producing transvenous tools/leads for Left Bundle Branch Area Pacing (LBBAP), excluding Medtronic. Includes product types, LBBAP labeling, regulatory status, and primary references.
Summary List
- Abbott — UltiPace™ stylet‑driven pacing lead; FDA-cleared for LBBAP.
- Boston Scientific — INGEVITY™+ pacing leads; FDA expanded indication for conduction system pacing of the LBBA (LBBAP).
- Biotronik — Solia S SDL + Selectra 3D delivery catheter; FDA indication specifically for LBBAP (lead + catheter combination).
- MicroPort CRM — Pacemaker systems (e.g., Alizea™, Borea™) with LBBAP workflow support and labeling (EU MDR/CE). Uses compatible third‑party leads/catheters.
Note: Medtronic’s SelectSecure™ 3830 lumenless lead remains widely used for LBBAP, but is excluded here as requested.
Detailed Table
| Manufacturer | Product(s) | Product Type | Lead Type | LBBAP Indication | Regulatory Status | Key Date | Typical Delivery | Primary Reference |
|---|---|---|---|---|---|---|---|---|
| Abbott | UltiPace™ | Pacing lead (SDL) | Stylet‑driven | Yes | FDA (USA); marketed internationally | 2024‑09 (public announcements) | Agilis HisPro™ or equivalent CSP catheters | Abbott — UltiPace |
| Boston Scientific | INGEVITY™+ | Pacing lead (SDL) | Stylet‑driven | Yes | FDA expanded indication (USA) | 2024‑09‑17 | Site Selective Pacing Catheters (SSPC/SSPC NXT) or equivalent | Boston Scientific — Press Release |
| Biotronik | Solia S lead + Selectra 3D catheter | Lead + delivery catheter | Stylet‑driven | Yes | FDA (USA) | 2024‑09‑16 | Selectra 3D (dedicated) | Biotronik — FDA Approval |
| MicroPort CRM | Alizea™, Borea™ systems | Pacemaker systems (programmer workflows) | — | Yes (system support) | EU MDR / CE | 2024‑08 (expanded labeling) | Vendor‑neutral; works with compatible LBBAP leads/catheters | MicroPort CRM — Alizea |
Clinical & Technical Notes
- Stylet‑driven leads (SDL) like UltiPace™, INGEVITY™+, and Solia S are now frequently used for LBBAP, with growing evidence of comparable success to lumenless alternatives when paired with appropriate sheaths.
- Dedicated delivery systems (e.g., Selectra 3D) may improve penetration and stability when targeting the left bundle branch area.
- Programming support at the system level (e.g., MicroPort CRM) helps standardize LBBAP workflows and follow‑up analytics.
References
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