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First received: May 10, 2023

Clinical Trial: Study of an Intrathecal Port and Catheter System for Subjects With Spinal Muscular Atrophy

Study Status: Completed

Recruit Status: RECRUITING

Condition: Spinal Muscular Atrophy

Study Type: INTERVENTIONAL


Official Title: Safety and Performance of the ThecaFlex DRx™ System Port and Catheter for Chronic Intrathecal Access, Cerebrospinal Fluid (CSF) Aspiration, and DElivery of Nusinersen in Spinal Muscular Atrophy (SMA)

Brief Summary: The primary objective of the clinical investigation is to demonstrate successful clinical use of the ThecaFlex DRx™ System in delivering nusinersen in subjects with spinal muscular atrophy (SMA).All enrolled subjects will undergo implantation of the investigational device (ThecaFlex DRx™ System) and will be followed for 12 months after receiving the implant.The 12-month data will be used to assess the primary endpoint support a Pre-Market Approval (PMA) application.

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