Adagio Medical launched an IDE clinical study of its next-generation vCLAS Ultra ventricular ablation system for sustained monomorphic ventricular tachycardia.
Results have not been presented; the update covers the first patient treated several weeks ago at Banner – University Medical Center Phoenix.
The procedure was reported as successful, with the patient doing well weeks later, supporting the system’s safety and effectiveness profile.
Trial data are intended to support a PMA supplement, while the first-generation vCLAS system’s PMA remains under FDA review.
Management expects the new system to streamline workflow and shorten procedures, strengthening its VT ablation positioning if confirmed in the study.
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