The purpose of this study is to provide continuing evaluation and reporting of safety and performance of the SynchroMed II Infusion System within its intended use. Data will support post-market surveillance obligations.
This study was originally posted under NCT01524276 and now posted alone to adapt to new ISO regulation.
Study Type
OBSERVATIONAL
Enrollment
209
Brugge
Bruges, Belgium
Leuven
Leuven, Belgium
Roeselare
Roeselare, Belgium
Sint-Niklaas
Pump accuracy
Demonstrate that the proportion of subjects treated as intended (p) with flow rate accuracy outside the interval of 0.75 to 1.25 (±25 percent) is \< 10 percent with 95 percent confidence at 4 years post implant.
Time frame: 4 years
Pump survival
Demonstrate pump survival (freedom from product performance events) is \> 90 percent at 4 years post-pump implant
Time frame: 4 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Sint-Niklaas, Belgium
Wilrijk
Wilrijk, Belgium
Praha
Prague, Czechia
Marseille
Marseille, France
Enschede
Enschede, Netherlands
Maastricht
Maastricht, Netherlands
Ljubljana
Ljubljana, Slovenia
...and 5 more locations