Artivion, a heart device manufacturer, recently faced a cybersecurity incident that prompted the company to take certain systems offline. The incident, which involved the acquisition and encryption of files, resulted in disruptions to order and shipping processes as well as corporate operations. While Artivion has been able to largely mitigate these disruptions, the company acknowledges the ongoing risks and potential for delays in system restoration.
The cybersecurity incident was identified on November 21, leading Artivion to initiate an investigation and engage external advisers in legal, cybersecurity, and forensics. The company is currently working to assess, contain, and remediate the incident, with a focus on securely restoring its systems in a timely manner.
Despite the incident, Artivion stated that it has not experienced a material impact on its financial condition or operations. However, the company anticipates incurring expenses related to its response and acknowledges that not all costs may be covered by insurance. In light of this incident, Artivion highlighted its cybersecurity risk management and strategy in its annual report released earlier this year.
In addition to addressing the cybersecurity incident, Artivion also announced an update on its AMDS Hybrid Prosthesis, aortic arch remodeling device. The device recently received a humanitarian device exemption from the FDA, allowing for distribution in the U.S. ahead of an anticipated premarket approval. CEO Pat Mackin shared that the company aims to secure PMA approval by the fourth quarter of 2025, unlocking a $150 million addressable market with no competitive alternatives in the U.S.
Mackin emphasized the positive impact of the AMDS Hybrid Prosthesis in reducing strokes and mortality rates, underscoring the potential benefits for patients. As Artivion navigates the aftermath of the cybersecurity incident and advances its medical device approval process, the company remains committed to delivering innovative solutions for cardiovascular care.
