General Investor Information EBR Systems, page-3

As part of my own due diligence on EBR I sought information on various matters that had been raised by another poster earlier on HC. I received the following response quite promptly from the CEO, John McCutcheon:

"Thank you for raising your concerns directly with us.

"HIS Pacing:
HIS Bundle pacing was an area of excitement 3 or 4 years ago, but interest dropped off dramatically after disappointing chronic results.
More recently, left bundle branch area pacing (LBBAP) has generated similar levels of interest. Studies are starting to appear to also show limitations with this approach using transvenous leads including acute failure rates (15%) and septal perforation rates (14%).
EBR believes that if this technique does become the standard of care, as the left bundle branch is located sub-endocardially on the left ventricular septum, the WiSE System is the best technology to deliver this approach.
A publication in Heart Rhythm Journal from 2022 (Feasibility of leadless left ventricular septal pacing with the WiSE CRT System to target the left bundle branch area: A porcine model and multicenter patient experience) demonstrated the feasibility of this approach using the WiSE System.

"Transvenous Leads:
By the nature of our indications today, all patients have an existing pacing, ICD or CRT system.
The WiSE System is implanted in patients who received ineffective CRT therapy or requiring an upgrade to CRT…without opening their existing pacemaker pocket or interfering with the veins carrying their existing leads.
An exciting area that is emerging is pairing the WiSE System with existing ‘leadless’ pacing systems that provide bradycardia pacing (eg, Micra, Aveir).
During the Asia Pacific Heart Rhythm Society meeting in Singapore in November 2022, Prof Pascal Defaye presented on the Technical Feasibility of Totally Leadless CRT Using a Leadless Pacemaker and a Leadless Left Ventricular Endocardial Pacing System. His conclusion was this was technically feasible with good clinical outcomes; and “the WiSE System remains the only means to upgrade the expanding population of Micra and Aveir patients to CRT”.

"Stroke Risk:
The WiSE Receiver Electrode becomes endothelialized (ie covered in heart tissue) within 30-45 days. The patient only takes dual-antiplatelet therapy for 3 months.

"Implant Technique / Duration:
In the SOLVE-CRT clinical study, we required implanters with no previous experience to perform a multi-stage implant, with the Battery & Transmitter implanted on day 1, the Receiver Electrode implanted on day 2. Following their initial implants, they typically move to perform a single stage implant.
The table below shows the dramatic drop-off in procedure time with experience. In fact, the 1h41m for the experienced WiSE implanters compares very favourably with published procedure times for conventional CRT procedures at 2h44m.
[Table not copied, due to HC editing problem or my use of it! - I will try to copy in a separate post later].

"I hope this addresses your concerns. Finally, we are excitedly anticipating the release of the SOLVE CRT results at the upcoming Heart Rhythm Society meeting in New Orleans in May 2023. Meanwhile, thank you for your continued support."

Needless to say I was impressed with the prompt response to each area I sought information on, and the fact each point was addressed in a positive manner (albeit from my minimal medical background).