Articles with "pivotal study" as a keyword



Multicenter Pivotal Study Demonstrates Safety and Efficacy of a New Cellulite Procedure: Final Results at 12 Months

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Published in 2022 at "Aesthetic Surgery Journal"

DOI: 10.1093/asj/sjac291

Abstract: Abstract Background Safety and efficacy endpoints for the single-arm, multicenter, open-label pivotal study, CONtrolled Focal Fibrous Band Release Method (CONFFIRM) [NCT04743635] assessing targeted verifiable subcision (TVS) for the treatment of cellulite were met at 3… read more here.

Keywords: safety; pivotal study; safety efficacy; efficacy ... See more keywords

Substernal lead removal: experience from the EV ICD pivotal study

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Published in 2024 at "Europace"

DOI: 10.1093/europace/euae102.445

Abstract: Abstract Background The extravascular implantable cardioverter defibrillator (EV ICD) has recently emerged as a new option for guideline indicated ICD patients. Previous study results from the EV ICD Pilot and Pivotal studies have demonstrated that… read more here.

Keywords: study; pivotal study; icd pivotal; lead removal ... See more keywords