Tuesday, June 18, 2024

Heart Devices: Getinge CEO Acknowledges Financial Impact of Suspension Due to FDA Concerns

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CEO Mattias Perjos acknowledged during a recent statement that the decision to suspend promotional activities for heart devices such as certain balloon pumps and cardiopulmonary bypass devices in the United States would inevitably lead to some adverse financial consequences for Getinge. However, he emphasized that the magnitude of these repercussions would be contingent upon the response from customers and other market factors. This announcement came shortly after the Food and Drug Administration (FDA) issued a directive instructing healthcare providers to cease the use of these specific heart devices due to safety concerns.

In his remarks, Perjos underscored the company’s commitment to prioritizing patient safety and regulatory compliance. He emphasized that while the decision to limit sales and promotional activities for these heart devices may have financial implications, the primary objective remains to ensure the welfare of patients and compliance with regulatory standards set forth by the FDA.

The decision to suspend promotional activities and restrict sales of the affected heart devices reflects Getinge’s proactive approach to addressing safety concerns and regulatory compliance. By aligning with the FDA’s directive and taking swift action to limit the availability of these heart devices, Getinge aims to mitigate potential risks to patients and uphold the highest standards of quality and safety in medical device manufacturing.

Getinge CEO Emphasizes Commitment to Transparency and Collaboration Amid Heart Devices Suspension

Perjos highlighted the importance of transparency and collaboration in navigating this situation. He emphasized that Getinge remains committed to working closely with regulatory authorities, healthcare providers, and other stakeholders to address safety concerns, implement necessary corrective actions, and ensure ongoing compliance with regulatory requirements.

Overall, while acknowledging the potential financial impact of the decision, Perjos reiterated Getinge’s unwavering commitment to patient safety and regulatory compliance. By taking proactive measures to address safety concerns and collaborate with stakeholders, Getinge aims to uphold its reputation as a trusted provider of medical devices while prioritizing the well-being of patients. During an analyst conference call on Wednesday, Getinge CEO Mattias Perjos acknowledged that the move would incur “some negative financial impact,” but emphasized that the ultimate effect would be contingent upon the reaction of customers.

Heart Devices

FDA Issues Warning on Getinge’s Cardiosave and Cardiohelp Devices Amid Multiple Recalls

The FDA cautioned healthcare providers against using Getinge’s Cardiosave intra-aortic balloon pumps and Cardiohelp cardiopulmonary bypass systems. This advisory came after the company initiated 20 recalls of these heart devices in less than 16 months. These recalls compounded existing quality concerns dating back to a 2015 consent decree. The FDA expressed dissatisfaction with Getinge’s responses to the issues, stating that the company had not adequately addressed the problems. Consequently, the agency recommended that providers explore alternative options.

Responding to the FDA’s actions, Getinge opted to halt promotional efforts and restrict sales of the affected heart devices, focusing on customers who lacked alternative options. Perjos clarified that these measures did not deviate from Getinge’s long-term strategy and noted that the FDA had not mandated any additional actions.

The company’s primary focus remains on resolving the remaining 10% of its quality record backlog, a task Perjos anticipated could take “a few weeks or months.” While no new significant findings have emerged, Getinge is actively addressing known issues, particularly those related to the balloon pump’s technical and engineering challenges.

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Getinge Plans FDA Submissions for Cardiohelp 2 and Cardiosave Plus Amid Financial Uncertainties

Looking ahead, Getinge aims to submit Cardiohelp 2 to the FDA by the end of the first half of 2025. Additionally, the company plans to seek clearance for updated HLS sets, a component of the Cardiohelp systems, later this year. Perjos refrained from providing a specific timeline for the HLS submission, citing the need for additional work before FDA submission. Furthermore, Getinge intends to submit Cardiosave Plus to the FDA in the second half of 2025.

Acknowledging the potential financial impact until the launch of new products, Perjos underscored that the extent of the impact remains uncertain, contingent on various factors such as customer behavior and competitor responses. The FDA is actively collaborating with other suppliers to ensure adequate market capacity, reflecting concerns over Getinge’s significant market share.

Getinge forecasts organic net sales growth of 3% to 6% through 2028, assuming no additional adverse financial impacts from Cardiohelp and Cardiosave beyond those known last week. While anticipating growth in China, the company expects the new normal to be high single digits, contrasting with the previous mid-teen increases.

 

Resource: Getinge, May 14, 2024

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