A bit of news from April 7.

U.S. health regulators approved the use of Abiomed Inc.'s micro heart pumps in patients with a type of heart failure known as cardiogenic shock.

Shares, up 37% over the past 12 months, rose 4.5% to $99.90 in after-hours trading.

The U.S. Food and Drug Administration had previously approved one of the Impella pumps to be used during elective and urgent high-risk angioplasties. The current approval expands the accepted uses for that pump system and includes three other systems.

The Danvers, Mass., company reported sales of $235.6 million for the nine months through Dec. 31, the most recent results available, and projected annual sales of $326 million, suggesting a 41% increase from the year earlier.


Q1 earnings due May 3. Y-O-Y earnings at Q4 were +38%, current p/e 34.7.



Hopefully this should accelerate their market penetration. They will be looking to capture as much this year before St Jude’s head to head trial results come out. Shares are up since this announcement. I will try and ride it until Q3/Q4 and maybe take money off the table as the head to head results are announced which I’m pretty sure will show a competitive advantage to St Jude’s, (although they will still need to secure license approval).

Anthonyms, I wonder if you have any more information on the STJ product and the level of risk it presents.

Because the company is so much bigger, it may attract credibility, or is this a situation where there is there room in the market for more than one player if the ABMD product is as good?


Googling “St. Judes Abiomed” returns 5 to 10 references to the head-to-head test being conducted. One of the shorter, direct-to-the-point ones is http://www.epvantage.com/Universal/View.aspx?type=Story&…

Other references give more detail comparing flow rates, device size…

Concern is that St. Jude’s (by memory) 100 times larger sales and marketing and they might have better results because their larger


Hi Strelna

I read a fool article and an SA article outlining how the St Jude’s device had a greater throughput pump rate. I’m pretty sure St Jude’s would have done its due diligence on the product before the acquisition so given all of that I would be astonished if its device didn’t show superiority.

Having said that it is benchmarking head to head against a soft target of ABMD and not the fastest pump (I think) so I don’t know what difference that will make.

What I do know though is that St Jude’s obviously has an in house care provider base to immediately adopt its own device into and is one of the most respected institutions world wide so I would imagine St Jude’s adoption would count for a lot with other institutions wanting to follow the leader and offer like for like gold standard care paradigms.

The question is whether the top end ABMD maintains an advantage, how much market it can lock up in advance, how long it would take the regulators to approve the St Jude’s device after the trial publication date.

Once in the market St Jude’s is so much bigger it will be a tough competitor for ABMD to try and match the Share of Voice with.


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Many thanks both, and Oforfive for the very informative link which makes the situation much clearer.

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Just wanted to add my knowledge of the situation. Again, I do procedures using similar techniques to those used with the Impella and HeartMate but do not specifically do interventional cardiology. Also I have worked at a few hospitals and have some background with regard to device selection and purchasing.

First, a brief comparison of Impella 2.5 and HeartMate PHP (which are the two being compared). The study being done is designed to be called a success even if the HeartMate is only slightly inferior to Impella but with the option of saying “but look it is actually better” if it so happens.

  • Both devices are placed using 13 French sheaths. The sheath is a plastic tube inserted into the artery to be used as a conduit for placing the device. The smaller then better, from an operator standpoint, and from a safety standpoint. So it’s basically a wash here. My guess is that doctors can learn to use either and it wouldn’t make much of a difference.

  • Impella 2.5 only pumps 2.5 Liters per minute while HeartMate does 4.0 Liters. This is the big selling point, but it’s unclear whether it makes a clinical difference. The devices are not being used in circulatory bypass, but rather to supplement a still working but weakened heart. A healthy heart does about 6 Liters at rest. So maybe 4.0 is overkill and makes no difference. It probably doesn’t hurt, unless the high flow rate affects the blood somehow (especially shearing the red blood cells which renders them much less effective).

  • Impella has a smaller profile across the aortic valve, while the HeartMate expands to a larger 24 French or so. This could be significant as one of the common co-morbidities in heart failure is aortic stenosis. Already the Impella is not supposed to be used in severe aortic stenosis. HeartMate is significantly larger. They might need to exclude anyone with an aortic valve diameter of 10 mm, which would mean the Impella might be more versatile (but of course not shown in the study). Also, the larger size might increase the risk of aortic valve damage, which could be catastrophic.

  • If both show similar functional profiles, the presence of severe complications would lead users to one device or the other. Impella has been proven to be safe. Possible such complications include heart failure (especially with aortic valve damage causing aortic regurgitation), shear injury to blood vessels causing anemia, and stroke (blood clots on the device going to the brain).

Assuming the St. Jude study shows non-inferiority, St. Jude does have a much larger footprint in cardiology departments and could use that to their advantage. It would be difficult for ABMD to compete, and most hospitals would probably go with St. Jude if all else is equal given existing relationships. But it could also further legitimize the practice and maybe even make Protected PCI more mainstream, giving ABMD a smaller piece of a much larger pie. There’s still room for smaller competitors, especially in smaller hospitals, where I’ve found that the smaller companies are able to provide better service. With new devices like this, early on it’s common that representatives will assist doctors with the first few cases. Being readily available for service and providing better training could help ABMD continue to grow though at a lower rate.

Personally I’ll be watching closely, and probably protect some of my gains ahead of the announcement, with hopes that the market will overreact and provide another entry point if the study is a success.