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ABMD

Abiomed

$284.00

-0.29 (-0.10%)

08:23
04/04/19
04/04
08:23
04/04/19
08:23

Abiomed says cardiogenic shock survival rates improve since Impella approval

Three years ago this week, Abiomed's Impella heart pump received its FDA PMA approval for AMI cardiogenic shock. At the time of Impella's FDA PMA approval, the cardiogenic shock survival rate to explant in the Impella Quality Assurance Database was 51% in the United States. Impella heart pumps, combined with the adoption of best practices, which include the use of Impella pre-PCI, have contributed to a significant increase in cardiogenic shock survival and native heart recovery. New data from the IQ Database on nearly 5,000 patients treated between April 2018 and March 2019 show an increase in survival from 51% to 67%2, a relative increase of 34% in survival. Since FDA PMA approval, Abiomed has collected data on nearly 100% of U.S. Impella patients in the observational IQ Database. This clinical data, combined with the FDA post-approval studies embedded in Abiomed's prospective cVAD Study, helped identify and validate best practices for Impella use associated with improved survival and native heart recovery. These best practices, including use of Impella pre-PCI, reduction of inotropes, early identification of shock, and hemodynamic monitoring with pulmonary artery catheters, have now been validated in multiple publications. The most recent results that further validate best practices published online this week in the Journal of the American College of Cardiology. After Inova Heart and Vascular Institute instituted a best practice protocol that includes early use of percutaneous mechanical circulatory support, AMI cardiogenic shock survival at 30 days rose from 44% to 82%.

  • 05

    Jun

ABMD Abiomed
$284.00

-0.29 (-0.10%)

02/04/19
PIPR
02/04/19
NO CHANGE
Target $480
PIPR
Overweight
Piper Jaffray expects impact on Abiomed from FDA letter to be minimal
Piper Jaffray analyst Matt O'Brien kept his Overweight rating and $480 price target on Abmiomed, saying there are nuances to the recent issuance of a "Dear Doctor" letter related to the Impella RP. The analyst notes that 16 of the 23 patients enrolled in the PAS "would not have met the enrollment criteria for the premarket study", so the survival in patients on protocal would have been higher than the 17% reported at 43% or 57%. O'Brien expects the impact of the letter to be minimal to RP utilization, stating that the opportunity for the program "remains healthy".
02/05/19
JEFF
02/05/19
NO CHANGE
Target $460
JEFF
Buy
Abiomed selloff on FDA letter to doctors overblown, says Jefferies
The selloff in shares of Abiomed after FDA notified doctors of higher mortality in the post approval study of Impella RP is overblown, Jefferies analyst Raj Denhoy tells investors in a research note. Sales of RP were 4% of sales in the most recent quarter at Abiomed, the analyst points out. Further, he sees "little risk" as the company "stresses timely and appropriate use of the pump." While there might be "some minor hiccup in sales to the tune of 1%-2%," there shouldn't be any lasting impact to the prospects of the RP pump, says Denhoy. Further, he believes the letter could have a "silver lining" as there is now evidence that the pump should be used sooner and patients not allowed to decompensation so dramatically before implantation. The analyst sees no impact to Abiomed's total addressable market and says the company remains the "best growth story in medtech." He keeps a Buy rating on the shares with a $460 price target.
02/05/19
WBLR
02/05/19
NO CHANGE
WBLR
Outperform
FDA letter adds 'question mark' to Abiomed story, says William Blair
The "Dear Doctor" letter, notifying clinicians of interim results from its post-approval study on Impella RP, "adds a question mark" to the Abiomed story, William Blair analyst Margaret Kaczor tells investors in a research note. However, from a fundamental perspective, Impella RP has been a relatively small part of Abiomed's revenues, contributing approximately $6.6M in its fiscal Q3. Thus, the analyst believes Abiomed can continue to grow over 20% over the next several years without significant contribution from Impella RP. Kaczor keeps an Outperform rating on Abiomed.
03/25/19
PIPR
03/25/19
NO CHANGE
PIPR
Piper sees six 'quality' Med Tech names whose stocks haven't rallied
Medical Technology stocks have rebounded quickly in Q1 following a challenging Q4 of 2018 as the combination of solid year-end results and compelling outlooks for next year have led investors back into the names, Piper Jaffray analyst Matt O'Brien tells investors in a research note. The analyst, however, has identified six "quality" names that have not participated in the Q1 share appreciation, "despite consistently delivering beat-and-raises." The basket of stocks include Abiomed (ABMD), Merit Medical (MMSI), AtriCure (ATRC), Neuronetics (STIM), SeaSpine (SPNE) and Nuvectra (NVTR).

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MSFT

Microsoft

$125.00

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FB

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CLB

Core Laboratories

$72.91

-1.605 (-2.15%)

17:42
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CLB

Core Laboratories

$72.91

-1.605 (-2.15%)

17:41
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MSFT

Microsoft

$125.00

-0.5 (-0.40%)

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TSLA

Tesla

$258.70

-5.15 (-1.95%)

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FB

Facebook

$182.64

-1.13 (-0.61%)

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PKG

Packaging Corp.

$98.86

0.33 (0.33%)

17:32
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Breaking Earnings news story on Packaging Corp. »

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PKG

Packaging Corp.

$98.86

0.33 (0.33%)

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TSLA

Tesla

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-5.15 (-1.95%)

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FOLD

Amicus

$13.15

-0.12 (-0.90%)

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FB

Facebook

$182.64

-1.13 (-0.61%)

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PKG

Packaging Corp.

$98.86

0.33 (0.33%)

17:29
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Earnings
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TSLA

Tesla

$258.70

-5.15 (-1.95%)

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Earnings
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MEOH

Methanex

$57.37

-1.63 (-2.76%)

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TSLA

Tesla

$258.70

-5.15 (-1.95%)

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MKGI

Monaker Group

$2.62

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TSLA

Tesla

$258.70

-5.15 (-1.95%)

17:26
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TSLA

Tesla

$258.70

-5.15 (-1.95%)

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