Catheter Precision announced that the patient follow-up phase for the VIVO European Registry has concluded. The EU registry began in October 2021 and patient enrollment concluded in June 2023. As previously disclosed, the EU registry enrolled 125 patients with an aim to gather real world data about the use and benefits of VIVO, outside of a rigorous clinical study. The data serves multiple purposes including fulfilling European regulatory requirements for on-going data collection, publication of multi-center data, and future development of studies and improvements to the VIVO technology, including a demonstration of the accuracy and benefits of VIVO for pre-procedure planning of ventricular ablation. The data is expected to become available in Q4 2024. In addition to the conclusion of the EU Registry, Catheter Precision continues the ongoing studies it has previously disclosed as part of its commitment to gathering and publishing clinical data for the company’s two product lines, VIVO and LockeT. The Company also announced additional initial evaluations of VIVO. During July, three new European hospitals are beginning product evaluations including Manchester University NHS, Wythenshawe Hospital, Institute for Clinical and Experimental Medicine, and Cardinal Massaia Hospital (Italy). In addition, two new US hospitals in California and Washington have been in-serviced and are scheduled to begin VIVO procedures this month as part of such initial evaluations.
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