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ABMD

Abiomed

$405.08

-8.51 (-2.06%)

13:44
11/11/18
11/11
13:44
11/11/18
13:44

Abiomed announces results of FDA STEMI door-to-unloading safety trial

Abiomed announces the results of the FDA STEMI Door-to-Unloading safety and feasibility randomized controlled trial, which show unloading the left ventricle with Impella CP for 30 minutes prior to reperfusion in patients presenting with anterior ST-segment elevation myocardial infarction without cardiogenic shock is safe and feasible, when compared to Impella patients reperfused immediately. The results of the prospective, 50 patient, randomized, multi-center trial were presented at Tufts Medical Center, at the American Heart Association Scientific Sessions 2018 in Chicago. The study found that unloading first and delaying reperfusion by 30 minutes did not increase 30-day major adverse cardiovascular and cerebrovascular events or infarct size, compared to the immediate reperfusion arm of the trial. Infarct size is a measure of damage to the heart muscle after a heart attack. It is feasible to delay reperfusion in a heart attack patient in a clinical trial, as demonstrated by a 100% adherence to the 30 minute unloading protocol and 100% Impella CP insertion success in both study arms. Unloading the left ventricle for 30 minutes prior to reperfusion appears to reduce infarct size as a percentage of area at risk among patients with a ST sum greater than 6. Abiomed also announces that, in agreement with the FDA, it will move forward with a pivotal, multi-center, prospective, randomized controlled trial comparing unloading with delayed reperfusion to the current standard of care. The pivotal trial is planned to begin next year. The safety and feasibility study design was approved by the FDA, with an independent steering committee and data and safety monitor overseeing the trial and a blinded clinical events committee independently adjudicating study endpoints. Infarct size was evaluated using a cardiac magnetic resonance imaging technique assessed at a blinded core lab. The trial was sponsored by Abiomed.

  • 27

    Nov

ABMD Abiomed
$405.08

-8.51 (-2.06%)

11/05/18
PIPR
11/05/18
NO CHANGE
Target $480
PIPR
Overweight
Abiomed feasibility study on Impella to be positive, says Piper Jaffray
The next catalyst for Abiomed following earnings last week is the release of the STEMI feasibility study on Impella in severe heart attack patients at the American Heart Association meeting in Chicago on November 11, Piper Jaffray analyst Matt O'Brien tells investors in a research note. The analyst anticipates the results of the feasibility study will prove positive and his analysis yields 200,000 U.S. STEMI patients and ~$5B market opportunity. A positive update on November 11 will likely push Abiomed shares even higher, O'Brien writes. He reiterates an Overweight rating on the shares with a $480 price target.
11/05/18
11/05/18
NO CHANGE
Target $400

Buy
Abiomed data could help double addressable market, says Jefferies
Abiomed will report data from its ST segment elevation myocardial infarction Door to Unloading study on November 11, Jefferies analyst Raj Denhoy tells investors in a research note. The analyst says that while only designed as a feasibility study with 50 patients, the rationale for the study and results from previous studies suggest it could show more than just equivalence. Any positive result would add support to the idea that Abiomed is well on its way to opening up a market of 200,000-300,000 patients per year worth $4B-$6B in the U.S. alone, says Denhoy. This would essentially double the addressable market for Impella, the analyst adds. He keeps a Buy rating on Abiomed with a $400 price target.
11/07/18
MSCO
11/07/18
UPGRADE
MSCO
Overweight
Abiomed upgraded to Overweight from Equal Weight at Morgan Stanley
11/07/18
11/07/18
UPGRADE
Target $496

Overweight
Abiomed upgraded to Overweight ahead of DTU trial readout at Morgan Stanley
As previously reported, Morgan Stanley analyst David Lewis upgraded Abiomed to Overweight from Equal Weight, stating that based on his review of pre-clinical and clinical data and physician conversations he has conviction in a positive readout from the Door to Unloading, or STEMI-DTU, trial next week. Data is to be presented at the American Heart Association Scientific Sessions on Sunday, November 11, the analyst noted. Abiomed's DTU trial challenges the current paradigm and success could result in a shift from the current standard of care, driving an inflection in valuation, Lewis tells investors. The ST-elevated myocardial infarctions, or STEMI, opportunity would expand Abiomed's current addressable market by about 70%, Lewis added. He raised his price target on Abiomed shares to $496 from $396.

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