Abiomed still fighting "misleading" studies against Impella effectiveness
Abiomed's Q3 2020 Earnings Call Is ABMD fighting against the "5 stages of grief / innovation acceptance"?. If so this could be only stage 1 or 2:
- Denial and Isolation.
On denial, isolation and anger
The equilibrium right now seems to be swinging back towards the surgeons who believe Impella is a harmful innovation. Is this simply denial or anger towards an innovation that these surgeons can't believe is necessary?
The Circulation publication is misleading because the authors manipulated a subset of 4% of our patients over a 10-year observational database and did not disclose the analytical methods to other researchers and waived the Institutional Review Board because the study was determined to not be "human subjects research."
Both the publication and the other presentation from nearly the same authors contain factual inaccuracies that demonstrate a lack of knowledge of the totality of the Impella data and FDA regulatory process. The Circulation paper and NCDR presentation, both excluded the sickest IAB patients who were escalated to other therapies and all ECMO patients which is the treatment most utilized at the authors' hospitals.
Abiomed requested that Circulation have the authors validate the data with another third-party research organization or the FDA directly to audit and scientifically validate what the authors state in the abstract and apply consistent standards to other observational studies. This request was denied. Based on the reputation of this journal, this paper is currently impacting Impella utilization, Impella physician referrals, and ultimately and most frustrating patient care in favor of inotropes, IABP, and ECMO with virtually no positive data on effectiveness and no independent FDA studies.
Abiomed has produced seven FDA studies, five post-market studies, has tracked over 6,000 patients in our CVAD registry study and has more than 115,000 patients in our IQ database.
We've invested over $100 million in this endeavor. Impella is the most studied heart pump in the history of the FDA with exclusive approval as safe and effective. Abiomed has supported or attempted seven randomized controlled trials, and we are currently enrolling our ninth Impella RCT. Abiomed recognizes that these patients are hard to randomize because they present ethical and logistical challenges for the physicians.
How the current expert advocates in the field respond:
The physicians that are the published experts are the ones that are currently enrolling. They are frustrated because the paper itself got more media attention and more press than some of the publications that show improvements in survival with nearly 95% native heart recovery. So, publications on best practices and shock like Inova or the Detroit Cardiogenic Shock Initiative, or the National Cardiogenic Shock Initiative, or the Hanover publication, or even the Shock Working Group. So, they are frustrated.
The second component, the Circulation paper declared that the sites that did the most or that the most experience had the worst outcomes, implying that they have the worst outcomes not that they're treating this -- a sicker population, and the challenge with the Circulation is that they're mixing high-risk PCI patients with shock patients, and we had sicker patients.
We also know that they eliminated patients that are escalated on a balloon pump, so they biased the data and took out the sickest balloon pump patients. So, they are frustrated and they are shocked it got published in Circulation, and they are also shocked that their conclusions were allowed to be so strong on an observational database. They have asked us to buy the data and get access to it, so that we can evaluate it and counter with the specific details, which we're doing for both the NCDR and this premier database, and they are galvanized.
So there, we - the positive of this is they are totally engaged. We know there has been more than five letters written to Circulation, none of which have been published that are very strong in favor of the clinical science.
On the Impella 5.5 roll-out
So Marie the Impella 5.5 is what I believe heart surgeons have wanted for the last 15 years. When I started at Abiomed we were a surgical company and people are always talking about a minimally invasive, longer term, wean-able pump, where you didn't have to core out the ventricle or you didn't have to crack open the chest. And so the Impella 5.5 is our first step into that equation, the Impella BTR pump will follow it.
That will be a longer-term VAD implanted a similar way, but it will run for more than a year and allow for patient discharge. On both the Impella 5.5 and the BTR pump, they will have SmartAssist. So we're able to actually monitor and see how the patient is doing. We're able to look for signs and predict recovery. And of course with Impella Connect we track that patient in the cloud.
And so – it’s an absolute breakthrough. Fortunately the surgeons are not as susceptible to the noise from AHA. We have huge demand. The feedback has been incredibly positive, especially since we've been able to duplicate that cardiomyopathy shock patients can actually return to baseline come off their inotropes and have their kidneys either recover or protected, which allows them to be explanted and go home without any further technology.
Such a big win, especially for a large population out there that’s 72 that's acutely decompensating and when they come in, you don't have a lot of options to get them back to baseline unless it's more invasive or an escalation to inotropic therapy, which has been proven to increase mortality. So we're super excited. The top centers, the top heart surgeons in the country have embraced it. We've done over 100 patients and the publication is pending. We also believe it's the most blood compatible pump and VAD ever created and we will be measuring and publishing that data as well.
And there's just a huge opportunity here as a forward flow pump because it does rest and recover the device with the heart, but as you wean it down, we can measure via the pressure volume loops, we can look at pressures in the LV and really get a good or have good timing on weaning somebody back almost the way you'd wean a hamstring.