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.