Xvivo has announced that the first patient has been enrolled as part of the continued access protocol (CAP) study for its heart technology, Xvivo Heart Assist Transport, in the USA.
This CAP study follows the PRESERVE trial and allows for the enrolment of up to 60 patients across 26 US transplant centres. The study has received continued cost recovery approval from the Centers for Medicare & Medicaid Services (CMS), providing essential access and support for both participating centres and patients.
The CAP, approved by the US Food and Drug Administration (FDA), allows for continued clinical use of the Xvivo Heart Assist Transport device while Xvivo collects and analyses one-year follow-up data from the PRESERVE trial in preparation for submitting its premarket approval (PMA) application.
The protocol closely mirrors that of the original IDE study, ensuring continuity in safety and efficacy data collection. The CAP will remain active until the FDA completes its PMA review or the maximum number of enrolled patients is reached.
“The continued access protocol 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,” says Jaya Tiwari, senior vice president, clinical and regulatory affairs, 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. The strong interest from participating sites further underscores the need for ongoing access to the Xvivo Heart Assist Transport.”
“The initiation of the PRESERVE CAP study and enrolment of the first patient marks another important step in our mission to bring innovative, life-saving technologies to patients in need,” says Christoffer Rosenblad, chief executive officer of Xvivo. “We are proud to see such strong interest from US transplant centres. Our vision is that nobody should die waiting for a new organ, and we remain committed to both realising this vision and supporting clinicians as they continue delivering advanced care with our heart technology.”
