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With regard to the substantial clinical improvement criterion, the applicant asserted that VEST represents a substantial clinical improvement over existing technologies because the strong clinical evidence showing the effect of VEST on the clinical outcome of CABG (multiple studies of different types with different, follow-up durations and with substantial endpoints) confirms the effect of VEST on (1) reducing incidence of cardiac events and the need for further interventions as a result of vein graft disease

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Size:50 g

Alternative therapies in health and medicine, 27(4), 8–13