How many conduction-system-pacing (CSP) leadless pacemakers are on the market as of May 28 2025?
GPT 3o:
None — as of May 28 2025 there are zero lead-free, conduction-system-pacing (CSP) pacemaker systems that are cleared for sale anywhere in the world.
| Company / system | CSP capability | Regulatory status (28 May 2025) |
|---|---|---|
| Abbott Aveir-CSP LP | Designed for left-bundle-branch & His-bundle pacing | In the global ASCEND-CSP pivotal trial; holds FDA Breakthrough Device designation but no market approval yet (Cardiovascular Business, PR Newswire) |
| Medtronic leadless LBBAP concept (Micra-based) | Pre-clinical / first-in-human feasibility only | Not submitted for approval; early animal & bench data presented 2024-25 (ScienceDirect) |
| Other vendors (Biotronik, EBR, etc.) | Offer leads or LV endocardial WiSE-CRT modules, not true leadless CSP | No CSP-leadless pacemaker on market (Cardiovascular Business) |
All commercially available leadless devices today (Abbott Aveir VR/DR, Medtronic Micra VR2/AV2) pace only the right-ventricular endocardium. Conduction-system targets (His bundle or left bundle branch area) remain investigational in the leadless format, so patients interested in CSP must still rely on conventional transvenous leads or enroll in ongoing trials.
Gemini :
As of May 28, 2025, there are no commercially available leadless pacemakers that perform full Conduction System Pacing (CSP), such as His-bundle pacing or left bundle branch area pacing (LBBAP), on the market for general use.
Here's the breakdown based on the latest information:
Current Leadless Pacemakers: The primary leadless pacemakers currently on the market are Medtronic's Micra (VR and AV2/VR2 versions) and Abbott's Aveir (VR and DR versions).1 These devices are designed for right ventricular pacing (VR), and in the case of Aveir DR, dual-chamber pacing through communication between two separate leadless devices (one in the atrium, one in the ventricle). While advanced, they are not designed for direct conduction system pacing.
Conduction System Pacing (CSP) Development: Conduction system pacing (His-bundle pacing, LBBAP) is a growing area for traditional, lead-based pacemakers because it provides more physiological heart activation. However, adapting this to leadless technology is highly complex due to the precise anatomical targeting required.
Investigational Leadless CSP: Abbott has been actively pursuing leadless CSP.2 Recent press releases (from late 2024 and April 2025) indicate they have successfully completed first-in-human feasibility studies for their investigational AVEIR Conduction System Pacing (CSP) leadless pacemaker system for LBBAP.3 This is a significant breakthrough, but it's important to stress that "investigational" means it is not yet commercially available or FDA-approved for general use. It's still in clinical trial stages.
EBR Systems WiSE® System: This is a leadless left ventricular endocardial pacing (LVEP) device that recently received FDA approval (April 2025) for Cardiac Resynchronization Therapy (CRT).4 While it's leadless and aims for more physiological LV activation, it's specifically for CRT and works as an adjunct to an existing right ventricular pacing system.5 It's not a standalone conduction system pacing pacemaker in the same vein as His or LBBAP for bradycardia.
In summary: