Results from cadaveric study of the InSpace™ balloon spacer vs. superior capsular reconstruction (SCR) in the treatment of massive, irreparable rotator cuff tears found that InSpace effectively restored the humeral head to a nearly normal position. SCR performed similarly, with no significant differences between the two techniques.
The study represents one of the first published biomechanical comparisons of InSpace, a biodegradable device, and the alternative SCR surgical technique in this application.
InSpace is implanted between the acromion and the humeral head, allowing for smooth gliding between the two bones. The device is CE Marked and marketed in Europe, Israel and parts of Asia and Latin America, and was granted an Investigational Device Exemption to conduct a pivotal human clinical study in the U.S.
Source: OrthoSpace Ltd.