PARIS--(BUSINESS WIRE)--Svelte Medical Systems, Inc. today reported 1-year clinical results from the DIRECT II study were similar to those seen at 6-months, with non-inferiority clearly established. Target Lesion Failure (TLF), a primary clinical indicator of device efficacy, increased from 2.8% at 6-months to 3.7% at 1-year in the Svelte arm, while TLF in the control arm reached 7.8% at the same 1-year time point. The Svelte arm also exhibited reduced procedure and device times, with trends toward reduced fluoroscopy time and contrast use compared with the control arm, confirming results observed in prior studies utilizing Svelte technologies.
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