OrthoSpace Initiates InSpace Trial Enrollment
OrthoSpace has begun enrolling patients in its U.S. study evaluating the InSpace biodegradable balloon system for repair of full thickness massive rotator cuff tears.
The multicenter clinical trial will enroll 184 patients and compare the device against conventional repair methods, the Israeli devicemaker said Monday.
The investigational study is meant to support an FDA 510(k) submission, with the implantations being the first of the device in the U.S.
InSpace is available for sale in Europe and Israel. — Jason Scott