This study is testing a device called the ThecaFlex DRx System for people with Spinal Muscular Atrophy (SMA) who need repeated doses of nusinersen (Spinraza). The ThecaFlex DRx System includes an implantable port and catheter designed to deliver nusinersen directly into the fluid around the spinal cord. You might be eligible if you are 3 years or older, have SMA, and have difficulty with standard lumbar punctures (spinal taps) due to other health issues. The main goals are to see how many people have the device successfully implanted and how many successfully receive nusinersen through it over 12 months. This study aims to show the device can be used effectively to deliver nusinersen.

Study design

This is a single-arm study, meaning all 90 participants will receive the ThecaFlex DRx System. It is a pivotal clinical investigation to assess the safety and performance of the device.

What's involved

You would undergo implantation of the ThecaFlex DRx System and be followed for 12 months. Nusinersen doses would be administered via the implant, with frequency depending on whether you have received nusinersen before.

Compensation

Not stated in the trial record.

Follow-up

Participants will be followed for 12 months after receiving the implant to assess the primary endpoints.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.