Abiomed (ABMD) said that the U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for its temporary Impella RP heart bump to treat patients suffering from COVID-19-related right heart failure.
Impella RP provides circulatory support for patients who develop right side ventricular failure. The device’s safety and efficacy is backed up by 5 years of pre- and post-market clinical studies, the company said.
“Impella RP may be effective at providing temporary right ventricular support for the treatment of acute right heart failure or decompensation caused by COVID-19 complications, including pulmonary embolism,” the FDA said.
The FDA approval means Impella RP is authorized to be used by healthcare providers in hospitals. In 2017, Impella RP received FDA approval as a safe and effective device for treating right ventricular failure in the setting of acute myocardial infarction and after cardiac surgery.
“Acute pulmonary embolism is clearly being recognized as a life-threatening manifestation of COVID-19. Impella RP is an important tool to help cardiologists save lives during this pandemic,” said Amir Kaki, an interventional cardiologist at Ascension St. John Hospital in Detroit. “Early recognition of right ventricular dysfunction and early placement of the Impella RP for patients who are hypotensive can be life-saving.”
Shares in the medical devices company declined 0.7% to $222.32 in morning U.S. trading trimming this year’s rally to 33%.
Five-star analyst Matthew O’Brien at Piper Sandler last week maintained his Buy rating on the stock with a $225 price target after Abiomed held an investor meeting offering positive data points.
The analyst noted that the discussion demonstrated “favorable mortality and ancillary benefits” from Impella, adding that “further data should drive more adoption in the high-risk percutaneous coronary intervention group, along with more severe heart failure cases expected due to COVID-19”.
Overall, Wall Street analysts have a cautious outlook when it comes to Abiomed’s stock. The Hold consensus consists of 2 Holds, 2 Buys, and 1 Sell. In view of this year’s stock surge, the $205.50 average price target indicates 7.8% downside potential in the coming 12 months. (See Abiomed stock analysis on TipRanks).
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