CAESAREA, Israel, Dec. 19, 2018 /PRNewswire-PRWeb/ -- OrthoSpace Ltd. ("OrthoSpace" or "the Company") today announced the publication of a new study in Arthroscopy evaluating the use of novel surgical techniques, including the OrthoSpace InSpace™ balloon spacer, to address massive irreparable rotator cuff tears (RCTs). These tears represent a painful, disabling condition for which there are historically few treatment options. The present study is unique because it represents one of the first published biomechanical comparisons of the InSpace balloon and the alternative surgical technique of superior capsular reconstruction (SCR) for the treatment of massive RCTs.
The cadaveric study, authored by Supriya Singh, M.D., George S. Athwal, M.D., FRCSC, and others, elucidates the biomechanical effects of massive RCTs and describes how the condition leads to humeral head migration, which is a likely source of patient symptoms. The authors assessed the impact of both InSpace, a biodegradable balloon spacer that is implanted between the acromion and the humeral head, allowing smooth gliding and frictionless movement between the two bones, and SCR on shoulder biomechanics.
The study simulated massive RCTs and loading forces on cadaver shoulders and found that the presence of a massive tear directly contributed to humeral head migration. When testing the impact of the novel surgical solutions, the authors found that the implantation of the InSpace balloon effectively restored the humeral head to a nearly normal position, a result which OrthoSpace believes may contribute to a reduction of pain leading to improved shoulder rehabilitation. SCR performed similarly, with no significant differences reported between the two techniques.
"Optimal surgical management of massive rotator cuff tears and the development of evidence based guidelines for treatment of massive rotator cuff tears are required. This patient population often suffers extreme pain and burdensome physical limitations," said George S. Athwal, M.D., FRCSC, one of the publication's authors. "This study represents an advancement in understanding through a laboratory setting of novel surgical techniques for the challenging indication of massive RCTs, demonstrating the compelling biomechanical performance of the InSpace balloon and inviting further clinical investigation."
Dr. Athwal's findings help to confirm the results of previously published clinical studies of InSpace. The study's conclusions validate how the InSpace balloon decreases superior humeral head migration and restores a more normal glenohumeral joint position.
"We congratulate Dr. Athwal and co-authors on the publication of this study, which deepens the body of understanding about complex shoulder biomechanics and the impact of innovative surgical techniques on shoulder anatomy and function," said Itay Barnea, CEO of OrthoSpace. "InSpace has been shown to reduce shoulder pain and improve function in extensive clinical use outside the U.S. and across multiple publications, and we welcome this rigorous insight into the device's performance and benefits as we continue to advance our clinical program."
About OrthoSpace Ltd.
OrthoSpace is a privately held medical device company located in Caesarea, Israel. The Company's product, InSpace, is an orthopedic biodegradable balloon system that is simple, safe and a minimally invasive method that addresses unmet clinical needs in rotator cuff repair. InSpace is CE Marked and commercialized in Europe, Israel and several countries in Asia and Latin America. OrthoSpace has been granted an Investigational Device Exemption (IDE) to conduct a pivotal human clinical study of the InSpace System in the United States.
SOURCE OrthoSpace Ltd.
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