A couple of interesting questions from
@simons77 I tried to piece my notes and investigated further.
At the Melbourne meeting it was stated that Abbot Laboratories have recently developed a dual chamber leadless (Right Atrium and Right Ventricle ) pacemaker. EBR’s sleuthing pointed to knowledge that Abbot’s pacemaker division grew by 10% in the last quarter (I think that was said). Now, we also heard that the single chamber pacing market is only 1/5 th of the dual chamber segment of the market. [How this was concluded was not elaborated upon). Based on the rate of growth by Medtronic’s single chamber pacemaker, and on Abbott’s estimated market growth just mentioned, we heard there could be 1 million leadless dual chamber pacemakers in 5 years.
To confirm and clarify, Abbot’s units are for the RA and RV, whereas EBR uses the LV only. Therefore there is no competition between the companies.Yet many patients who are implanted with Abbot’s devices will NEED EBR’s device. This is because of a thing called pacing induced heart failure. See
https://aseanheartjournal.com/10-31762-ahj2332-0302-fulltext/ Otherwise known as Pacing Induced CardioMyopathy. Another article clarifies that the problem is induced by artificial pacing
https://www.mdpi.com/1648-9144/58/9/1283So biventicular pacing, or CRT, is the standard of care for pacing induced cardiomyopathy (heart failure ) So it is indeed a captive market for EBR, to quote Andrew Shute. According to the first article I linked, about 20% of patients will develop PICM in about 3 years! And because Abbott’s LV solution is still NOT leadless their new product still won’t totally work. Physicians know this.
This news about Abbott is indeed a good reason to upwardly revise the total addressable market. That’s if we assume Andrew Shute’s estimations are correct. I’m reading his statement to mean that dual chambered devices will create new demand. We already know lead complications/difficulties in placing leads in CRT devices will affect about 30% of patients. So this is a new catalyst.
Somebody at the Melbourne meeting asked if EBR’s device could be used in the right ventricle. While the answer was ‘yes’ it is not EBR’s strategy to compete with exisiting products. But it CAN work! Wouldn’t Abbott and Medtronic love permission to either licence the technology or buy the patents with the company? Miniaturisation is a big deal, and EBR have actually been working on this for 20 years. A miniaturised device enables better physiologic placement, resulting in less chance of unwanted nerve stimulation and more precisely targeted desired nerve stimulation. There is literature around these benefits e.g.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8076968/Another comment from the floor was along the lines of ’if the left ventricle is so important why haven’t the pacemaker companies done anything about it?’ As JM said it’s a big task. EBR’s technology is the result of 2 decades of R&D, which is why the FDA awarded its product ‘breakthrough device designation’. Andrew Shute said this has facilitated the product’s impending reimbursement status in the US hospital system. I suspect this is why EBR have revised their unit selling price from $US 35000 to $US 45000.
It’s worth remembering not only how important EBR’s breakthrough device designation is, but what it signifies to the market. See
https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program To qualify, you need to show
-it provides for more effective treatment or diagnosis of life-threatening or irreversibly, debilitating human disease, or conditions.
It needs to meet at least one of the following
a) represent breakthrough technology
b) no approved or cleared alternative exist.
c) offers significant advantages over existing approved or cleared alternatives.
d) device availability is in the best interests of patients.
I think EBR meets all the criteria!
If you check that FDA link you’ll find Abbott was a recent recipient, but I don’t know if it was for their latest CRT.
All right
@simons77, you’ve heard about this obviously
https://academic.oup.com/europace/article/25/10/euad285/7274809But that issue (CRT-D versus CRT-P) is a non-issue for the WiSE device. Because WiSE works with whatever works.
Hope my comments were helpful.
(20min delay)