Xvivo announced it enrolled the first patient as part of a continued access protocol (CAP) study for its Heart Assist Transport system.
The CAP study follows the PRESERVE trial of the Xvivo system in the U.S. It allows for the enrollment of up to 60 patients across 26 U.S. transplant centers. Additionally, the study received continued cost recovery approval from CMS to support both participating centers and patients.
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Gothenburg, Sweden-based Xvivo said the FDA-approved CAP allows for the continued clinical use of its Heart Assist Transport device as it collects and analyzes one-year follow-up data from PRESERVE in preparation for submitting a premarket approval (PMA) application.
The company said the study’s protocol closely mirrors that of its original investigational device exemption (IDE) study. It expects the CAP to remain active until the FDA completes its PMA review or the study reaches the maximum number of enrollees.
“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 U.S. 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.”
