OrthoSpace has enrolled the first three patients in its United States investigational device exemption pivotal study.
Here are five things to know:
1. The study will compare the company's InSpace product to conventional repair or partial repair for the treatment of full thickness massive rotator cuff tears.
2. InSpace is an orthopedic biodegradable balloon system.
3. The IDE study will include 184 subjects.
4. The system has been implanted in more than 5,000 patients in 15 countries.
5. Edwin J. Rogusky, MD, and Paul R. Sensiba, MD, performed the procedures at University Orthopedics Center in State College, Pa. It was the first time the balloon has been implanted in the United States.