Getinge limits sale of heart devices in the US after FDA warning

Getinge publ AB

15/05/2024 07:35

May 15 (Reuters) - Sweden's Getinge  GETIb.ST  will
limit sales of some of its heart products in the U.S., the
medical equipment maker said late on Tuesday, after recent
advice from the U.S. Food and Drug Administration (FDA) to move
away from its devices. 
    "We have decided to immediately pause promotional activities
of the Cardiohelp System and Cardiosave Intra-Aortic Balloon
Pump in the U.S. until outstanding actions related to quality
improvements have been addressed and approved," said CEO Mattias
Perjos in a statement.
    Getinge would limit sales of the two products in the U.S. to
customers who had no available alternatives, it said. 
    The company has struggled to resolve quality problems with
its heart pumps and with sterile packaging of products for
heart-lung support systems, that have squeezed its margins and
knocked its shares since the second quarter last year.
    It now targets over 12% growth on average in its adjusted
earnings per share (EPS) for 2024-2028, the company said,
compared to its previous target for over 10% growth in EPS for
2022-2025.
    Getinge said that until new products are approved and
launched, its finances would be negatively affected, but that it
was too early to have a "firm opinion on the exact extent" of
the impact.
    The maker of products for surgery, intensive care and
sterilisation will host a capital markets call for investors on
Wednesday.

 (Reporting by Greta Rosen Fondahn, editing by Terje Solsvik)
 ((Greta.RosenFondahn@thomsonreuters.com))