XVIVO Perfusion AB announced the enrollment of the first patient in its US PRESERVE Continued Access Protocol (CAP) study for the XVIVO Heart Assist Transport device, marking a significant milestone in the company's regulatory pathway toward full market approval. The CAP study, approved by the US Food and Drug Administration, allows for the enrollment of up to 60 patients across 26 US transplant centers while the company prepares its Pre-Market Approval application.
Regulatory Bridge to Market Access
The CAP study follows the successful completion of XVIVO's PRESERVE Trial and serves as a regulatory bridge allowing continued clinical use of the heart transport technology. The protocol closely mirrors that of the original IDE study, ensuring continuity in safety and efficacy data collection while XVIVO analyzes one-year follow-up data from the PRESERVE trial.
"The Continued Access Protocol (CAP) study ensures that patients awaiting heart transplants can continue to benefit from XVIVO's heart technology, even as the FDA receives and evaluates our PMA submission," said Jaya Tiwari, SVP Clinical and Regulatory Affairs at XVIVO. "The FDA and CMS approvals provide an important mechanism to maintain clinical use during this interim period, supporting continuity of care while the technology's safety and efficacy continue to be formally evaluated."
Financial Support Secured
The study has received continued cost recovery approval from the Centers for Medicare & Medicaid Services (CMS), providing essential access and financial support for both participating centers and patients. This approval addresses a critical barrier to access during the regulatory review period, ensuring that transplant centers can continue offering the technology to eligible patients.
The CAP will remain active until the FDA completes its PMA review or the maximum number of enrolled patients is reached, providing flexibility in the regulatory timeline while maintaining patient access to the innovative heart preservation technology.
Clinical Impact and Future Vision
"The initiation of the PRESERVE CAP study and enrollment of the first patient marks another important step in our mission to bring innovative, life-saving technologies to patients in need," said Christoffer Rosenblad, CEO of XVIVO. "We are proud to see such strong interest from US transplant centers. Our vision is that nobody should die waiting for a new organ, and we remain committed to both realizing this vision and supporting clinicians as they continue delivering advanced care with our heart technology."
The strong interest from participating sites underscores the clinical need for ongoing access to the XVIVO Heart Assist Transport technology during the regulatory review period. XVIVO, founded in 1998, positions itself as the only medical technology company dedicated to extending the life of all major organs, enabling transplant teams worldwide to save more lives.
