2 results
Approved WMORecruiting
There are two treatment groups in this study: one with participants at low risk of deterioration and one with participants at standard risk of deterioration. The primary objective for each group is described below.-Low Risk group: To describe the…
Approved WMORecruiting
The purpose of the INTIBIA pivotal study is to demonstrate the safety and effectiveness of the INTIBIA System in the intended population through 24 months of follow-up. Data at 12-months will be used to support regulatory approval.The objective of…