Dive Brief:

• Getinge said Tuesday it has paused promotional activities of certain balloon pumps and cardiopulmonary bypass devices in the U.S.
• The company, which is limiting sales to customers that lack alternatives, took the action days after the Food and Drug Administration told healthcare providers to stop using the devices.
• Getinge CEO Mattias Perjos said Wednesday on an analyst conference call the action will have “some negative financial impact,” but the full effect will depend on how customers respond.

Dive Insight:

Last week, the FDA advised providers against using Getinge’s Cardiosave intra-aortic balloon pumps and Cardiohelp cardiopulmonary bypass systems after seeing the company start 20 recalls of the devices in less than 16 months. Those recalls added to a string of quality concerns dating back to before a 2015 consent decree.

The FDA said Getinge has yet to “sufficiently” address the problems and advised providers to look for alternatives.

Getinge, which estimates it controls more than 60% of the U.S. market for the affected products, responded to the FDA’s action by pausing promotion and limiting sales of the devices. Perjos said the actions do not affect Getinge’s long-term plan, adding that the FDA has not asked Getinge to take any additional actions.

The focus is still on working through the remaining 10% of the quality record backlog, something Perjos said could take “a few weeks or months.” Getinge has made no new material findings, Perjos said, and is working to fix known issues. 

“It is related to working through the challenges on the balloon pump itself. There's some technical and engineering challenges here that we need to work through,” the CEO said. “Making good progress, but it is rather complex work that is required.” 

Getinge aims to submit Cardiohelp 2 to the FDA toward the end of the first half of 2025, according to Perjos. Later this year, the company will file for clearance of updated HLS sets, a component of the Cardiohelp systems the FDA also referred to in its letter to providers.

Perjos declined to give analysts a timeline for the HLS submission. Getinge has filed for a CE mark for HLS sets but needs to do additional work before submitting the product to the FDA, and the company plans to submit Cardiosave Plus to the FDA in the second half of 2025, added the CEO. 

The company expects to take a financial hit until the new products are launched, but it is too early to tell exactly how it will be affected. Perjos said the impact depends on factors that are at least partly beyond Getinge’s control, such as the behavior of customers and competitors. The FDA is working with other suppliers “to be able to fill the capacity that the market needs,” the CEO said. 

“When it comes to FDA pushing new suppliers, yes, I think this has been known for a while that they're not happy that we have the large market share that we have in the U.S.,” Perjos said. “They think it’s a bit too vulnerable.”

Getinge forecast 3% to 6% in organic net sales growth through 2028. The forecast assumes there will not be additional negative financial impact from Cardiohelp and Cardiosave beyond what Getinge was aware of last week. Getinge expects China to return to growth but for the new normal to be high single digits, rather than the mid-teen increases seen previously.