ABMD - No Panic!

There is absolutely no need for panic and the TAM will be negligibly affected if at all, see ABMD figures below.

HeartMD is probably still working so let me give you some background on ABMD’s heart pump catheters, the indication for their use, and the percentage of each device that makes up ABMD’s use and revenue from each. I recommend to read the articles and slides linked as it will help you understand what the indications are for the use of ABMD’s various Impella heart pumps. I also seems to me people confused the Impella CP with the Impella RP or don’t know the difference. Here are the things you need to know to adequately assess the importance or non-importance of the FDA letter, https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCar….

Heart Failure - what you need to know

Heart failure (HF) is the most common reason people over 65 are admitted to the hospital and “can involve just one side of the heart or both sides. In most cases, it affects the left side first. H usually broken down into several types:

1. Left-sided heart failure: The left ventricle is larger and pumps more of the heart’s blood. This type of heart failure is broken down into two categories:

Systolic failure, where the left ventricle is too weak to push enough blood

Diastolic failure, where the left ventricle is too stiff, can’t relax, and can’t fill with blood normally

2. Right-sided heart failure: This usually happens after the left side fails. More fluid pressure through the lungs damages the right side of your heart.

Congestive heart failure:
When blood slows down as it leaves the heart, it also is slower when it comes back. That causes blood to back up in your veins, and there can be swelling all over your body. You might see it in your legs and ankles, but it can collect in your lungs, too. That can cause serious breathing problems." (https://www.webmd.com/heart-disease/heart-failure/what-is-he…)

Patients are usually seen when the left-side of the heart starts failing and are treated BEFORE the right side also fails. When both sides of the heart fail to pump adequately, the patient will be extremely ill and mortality is very high. As RoyGeeBiv highlighted “Although the FDA is concerned about the high mortality rate from the interim PAS results, we believe that when the device is used for the currently approved indication in appropriately selected patients, the benefits of the Impella RP system continue to outweigh the risks. Our current analysis of these results and recommendations for health care providers who may use the Impella RP System follow below.” (https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCar…)

Since left-sided HF is much more common than right-sided HF, most Impella pumps are for the left side of the heart, inserted via femoral or axially ARTERIES. For right-sided HF, the device is inserted through the femoral VEIN.

U.S. Current Addressable Market (CAM)

					Annual No. of High Risk Patient:
Protected PCI (Left-side)		121,000 }             (Elective & Urgent)
Emergent	(Left-side)		100,000 }   95.7%
Right-sided HF				 10,000      4.3%
**Total CAM				231,000**

ABMD Total Market Penetration 11%
From: JPM HC conf. Pres_2019-01-07, http://investors.abiomed.com/static-files/2b99ac60-d848-4b71…

ABMD’s Impella Portfolio currently in Use in the US

__2.5 Platforms	        Flow Rate     Insertion        FDA approved      Use Duration        CE*__
                          Up To			                                 in US

Impella 2.5	        2.5 L/m	      femoral a. 	     Yes	    up to 5 days     2004-09

Impella CP*         	4.3 L/m	      femoral a.	   2012-09-10       up to 5 days     2012-04-12

Impella CP* w/
   Smart Assist	        4.3 L/m	      femoral a.	   2018-04-02	    up to 5 days	
  & optic. sensor  				

**5.0 Platforms**					
Impella 5.0	        5.0 L/m	      femoral a.
		                  or axillary a.	      Yes	    up to 10 days    2003-01

Impella LD	        5.0 L/m	     open chest	              Yes	    up to 10 days    2002-06

**Impella RP**	        4.0 L/m	      fem.VEIN	         IDE 2012-11-12      14 days 	     2014-04-08
 (right heart)			                         HDE 2015-01-27		

*Impella CP (Note two values given, 4.0 L/m in brochure, 4.4L/m on website)
PMA - Pre-Market Approval by FDAs Center for Devices and Radiological Health (CDRH)
IDE - Investigational Device Exemption
HDE - Humanitarian Device Exemption
**Conformité Européenne (European health & safety product label) - https://ec.europa.eu/growth/single-market/ce-marking_en

ABMD Revenue by Impella Device, Q3 FY2019, Jan.31, 2019)

Impella **CP**     (left-sided)         76%
Impella 2.5    (left-sided)         12%
Impella 5.0    (left-sided)          8%      

Impella **RP**   (right-sided)           4%

From slide #3, Q3 FY 2019 Earnings Call, https://seekingalpha.com/article/4237039-abiomed-inc-2019-q3….

As you see, 96% of the procedures done with Impella devices are done for left-sided HF, only 4% for right-sided HF. This will hold true for other countries and the TAM will expand. People live longer, wealth has created an increase in obesity, high blood pressure and adult onset diabetes, the latter is already found in US children!

About 35% of our illnesses are determined by genes, 65% by lifestyle. Both heart disease (globally the number one cause of death) and cancer are linked to lifestyle, so my recommendation is: Don’t smoke, drink very little if at all, exercise, eat a mediterranean diet with lots of vegetables, very little or no meat and you may never have to endure an Impella procedure.

Hope this was helpful in clarifying some of the issues.



My thoughts are here:


This does not concern me nor affect the investment thesis in a material way.




I was so frustrated with the tables (there ought to be an easier way!), I incorrectly stated that 96% of the procedures done with Impella devices are done for left-sided “HF”. What I should have said, 96% of the Impella Pumps are inserted into the left side of the heart or the left ventricle.

96% of the procedures are used for Protected PCI AND in cardiogenic shock, with the Impella inserted into the left ventricle. Only 4% of the procedures are done for right-sided heart failure.


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Details of Impella RP can be found here:


The total number of patients is 60. Would love for others who know more about the data below to please expound. Thanks!

Impella RP PMA Cohort Study Results (N=60)			Survival Rates
PMA Subjects (RR + CAP + HDE PAS) – full cohort (N=60)		73% (44/60)
Cohort A (N=31)							77% (24/31)
Cohort B (N=29)							69% (20/29)
								Journal of Heart and Lung Transplant, December 2018(37)

On January 31, 2019, Abiomed proactively sent physicians who use Impella RP post-approval study (PAS) data that provides additional evidence of
the benefits of following proper protocols for placement of Impella RP. The data is summarized in the table below and demonstrates the importance of
early placement of Impella RP, and the importance of following proper inclusion and exclusion criteria when selecting patients for Impella RP.

The PMA cohort (n=60) had 73% survival and the PAS cohort (n=23) is currently at 17%. This PAS population has 70% (16/23) outside the
recommended treatment protocol inclusion and exclusion criteria, and as a result survival rates are lower. These patients were critically ill and, in some
cases, had been in profound shock for more than 48 hours. As such, these patients were statistically sicker and may not have been appropriate
candidates to benefit from right side mechanical circulatory support.

											Impella RP	Impella RP
											Pre-Market	Post-Market
											Study		(PMS) Report
Characteristics										(N=60 Patients)	(N=23 Patients) P-Value
Mean±SD(N) 										58.58±15.12(60) 65.61±13.72(23) 0.056
Did the patient experience an in-hospital cardiac arrest prior to Impella implant 	0.00% (0/60) 	56.52% (13/23) 	<.001
At the time of Impella implant did the patient receive CPR/ACLS 			0.05% (3/60) 	30.43% (7/23) 	<.001
Was there evidence of hypoxicischemic brain injury prior to Impella implant 		0.00% (0/60) 	14.29% (3/21) 	0.016
Was the patient supported with inotrope or vasopressors prior to Impella implant 	98.33% (59/60) 	86.96% (20/23) 	0.063
If yes, Indicate total number of inotrope or vasopressors
Mean±SD(N) 										3.37±1.24(59) 	4.38±1.56(13) 	0.014
Median 											3.00 		4.00
Range (Min, Max) 									(1.00,6.00) 	(2.00,8.00)
Patients in shock >=48 hours 								0.00% (0/34) 	26.09% (6/23) 	<.001
IABP used prior to Impella implant 							0.00% (0/60) 	30.43% (7/23) 	<.001