ABMD from the front lines

CUrrent AHA guidelines recommend patients with hemodynamic or electrical instability to urgently / emergently go to the cath lab (and really, what else is more unstable than say, a cardiac arrest). 50% of cardiac arrest patients - even those without evidence of an active heart attack on their initial ekg - will have an acute coronary occlusion amenable to stenting. and these patients actually do reasonably well.

Now, this has been in the guidelines since, I believe, 2007, and only now is it becoming fashionable to take them to the cath lab. Though, eventually, I believe we’ll get there. The knowledge translation window for things like this to disseminate and become a part of medical culture is about 12-16 years, so were about halfway there.

So why do I mention this? Well, first, the numbers are small, but ABMD analyzed ten consecutive hemodynamically unstable patients that would have otherwise been excluded from PROTECT-II, and used the IMPELLA system. Compared to what you would expect, they did quite well. This should lead to “indication creep” whereby, if you were a cardiologist regularly using IMPELLA over an intra-aortic balloon pump, and you know that the IMPELLA in “normal” cases offers a slight advantage, why not use it over the IABP in a higher risk scenario and attempt to improve morbidity and mortality? Once they increase usage of IMPELLA for routine cases, the next step is to push for it as a bridge in the acutely unstable patient (ie, the example discussed above). Now, this wont be a tremendously large patient population, but enough to make a dent in earnings if it becomes standard at every cath facility.

I see additional benefits to IMPELLA in the future, and wouldnt be at all surprised if ABMD got scooped up by a larger player (St Jude?) within the next few years.

11 Likes

Hi Fuma, Thanks for your comments on ABMD from the front lines. I assume you work in the field?
Saul

I am not a cardiologist, but I do work with catheters and the same techniques as an interventional radiologist. I got interested in this company after hearing some cardiologists discussung it. I did start a position because I think the device is still in its infancy and will continue to grow for a while.

The main differentiator in the Impella products is that they were designed primarily as catheter based systems, rather than a catheter implementation of a surgical device (which is what the intra-aortic balloon pumps look like). I think they can continue to make it smaller and with that the downsides to putting one in drop significantly. If they can get down to an 8 French sheath size most closure devices will be compatible and really it would be an added 10-15 minutes of procedure time to place an Impella (I don’t know how long it really takes to set up, but it should onky take that long to access the artery, place and position the catheter, then remove the catheter and place an arterial closure device). Being easy to use goes a long way in adoption in the interventional cardiology field.

I think it may even go the other way, where cardiologists stretch the “high risk” definition to include more routine patients, use the Impella, just for a bit of added protection. This is assuming that the reimbursement is a net positive. With a smaller catheter size, the downsides to putting one in are reduced such that the potential benefits can be lower and still outweigh the risks.

I can also see in the future extension of the catheter to a biventricular assist by running the motor in reverse in the right atrium across the pulmonic valve. Also, some will probably use it for longer term ventricular assist than the currently documented 6 hours, possibly as a bridge to transplant.

In the end, the reality is that the success or failure of medical devices has as much to do with regulatory issues (they already got their approval) and physician preference as actual medical benefit. I did well with ISRG knowing that even though the da Vinci prostatectomy is probably no better than laparoscopic techniques, urologists preferred it and could market it, so it became the only thing they offered. A cardiologist would not tell a patient that for an extra $x they could have the Impella assist device. They’ll just say that they use this device, it protects their body during intervention and shortly thereafter, and patients will just agree.

Saul and others can probably provide a better look into the financials. I am still learning the financial side of things so I try to focus on companies and industries that I think have staying power.

26 Likes

I am not a cardiologist, but I do work with catheters and the same techniques as an interventional radiologist. I got interested in this company after hearing some cardiologists discussung it. I did start a position because I think the device is still in its infancy and will continue to grow for a while.

The main differentiator in the Impella products is that they were designed primarily as catheter based systems, rather than a catheter implementation of a surgical device (which is what the intra-aortic balloon pumps look like). I think they can continue to make it smaller and with that the downsides to putting one in drop significantly. If they can get down to an 8 French sheath size most closure devices will be compatible and really it would be an added 10-15 minutes of procedure time to place an Impella (I don’t know how long it really takes to set up, but it should onky take that long to access the artery, place and position the catheter, then remove the catheter and place an arterial closure device). Being easy to use goes a long way in adoption in the interventional cardiology field.

I think it may even go the other way, where cardiologists stretch the “high risk” definition to include more routine patients, use the Impella, just for a bit of added protection. This is assuming that the reimbursement is a net positive. With a smaller catheter size, the downsides to putting one in are reduced such that the potential benefits can be lower and still outweigh the risks.

I can also see in the future extension of the catheter to a biventricular assist by running the motor in reverse in the right atrium across the pulmonic valve. Also, some will probably use it for longer term ventricular assist than the currently documented 6 hours, possibly as a bridge to transplant.

Wow, IRdoc, great discussion from the field! Thanks!
Saul

1 Like