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

[May 15, 2024]  (Reuters) - Sweden's Getinge 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 sterilization will host a capital markets call for investors on Wednesday.

(Reporting by Greta Rosen Fondahn, editing by Terje Solsvik)

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