3 results
Approved WMOCompleted
Primary objectives of this study:1. Evaluate the efficacy after 26 weeks of Kuvan® treatment + Phe-restricted diet therapy in increasing dietary Phe tolerance, as compared to dietary therapy alone in <4 year-old infants and children with…
Approved WMOCompleted
The primary objective of this clinical investigation is to demonstrate that the qualification rate with anatomic lead placement is non-inferior to the qualification rate with targeted lead placement (tonic paresthesia guided) for the BurstDRTM trial…
Approved WMOCompleted
Evaluate the safety and feasibility of providing automated tactile stimulation in response to apnea, bradycardia and/or desaturation using the BreatheBuddy.