OrthoSpace Begins U.S. IDE Trial

Caesarea, Israel-based OrthoSpace Ltd. has enrolled the first three patients in its U.S. investigational device exemption (IDE) pivotal study. The study is a 184 patient randomized, single blinded control study that compares the company’s Inspace biodegradable balloon system to conventional repair or partial repair for the treatment of full thickness massive rotator cuff tears. While Inspace is currently commercially available outside of the United States and has been implanted in over 5,000 patients in 15 countries, the trial will be the first time the device is implanted in the United States.

Edwin J. Rogusky, M.D., and Paul R. Sensiba, M.D., performed the procedures earlier this week at University Orthopedics Center in State College, Pa.

“We are honored to be a part of this study and to initiate clinical study enrollment,” they said following the first three procedures. “The data to date has demonstrated Inspace’s safety and efficacy, and we look forward to contributing to the U.S. dataset to facilitate Inspace’s entry into the U.S. market.”

“Having heard about promising results with the use of this technology from our colleagues abroad and having seen the procedure in Europe, I am looking forward to leading this talented group of U.S. surgeons in completing this pivotal study that will hopefully allow us to bring this innovation to the United States,” said Nikhil N. Verma, M.D., of Rush University Medical Center, the primary investigator of the study. “Inspace addresses a current unmet medical need for my patient population: a simple, minimally invasive way to treat massive rotator cuff pathology, with limited recovery time for the patient.”

Enrollment in the study is ongoing, and patients are being recruited at multiple sites across the country.