CAESAREA, ISRAEL (PRWEB) DECEMBER 16, 2016
OrthoSpace Ltd. (“OrthoSpace” or “Company”) today announced a publication in the December issue of Musculoskeletal Surgery citing positive results for their InSpace System in the surgical treatment of massive rotator cuff tears (MRCTs). Patients undergoing the InSpace procedure experienced durable improvements in shoulder function and reductions in shoulder pain at 12 months of follow-up, demonstrating the benefits of InSpace as an effective alternative to existing surgical treatments.
The InSpace System consists of a biodegradable balloon spacer that is implanted in the subacromial space of the shoulder. InSpace is designed to address the challenges of MRCTs where surgery often fails and for which there is not current consensus or definitive guidelines for optimal surgical treatment. The procedure may be performed arthroscopically, or under fluoroscopy guidance, as presented in the study.
Patients with advanced age, diminished health status and comorbidities such as cardiovascular disease may be at a higher risk for complications when subjected to general anesthesia. The option to receive InSpace under fluoroscopy guidance addresses the unmet needs associated with this patient population, as the procedure is performed under local anesthesia.
“InSpace has been demonstrated to improve patient shoulder function and reduce pain in a difficult-to-treat population where conservative options have been exhausted and surgery under anesthesia would pose high risks to the patient,” said Enrico Gervasi, M.D., the study’s principal investigator and the Director of Orthopedic and Trauma Surgery at Latisana Civil Hospital at Udine, Italy. “Further, the procedure is technically easy to perform, taking only ten minutes to deploy the spacer, and can be performed under local anesthesia in the outpatient setting.”
This ongoing clinical study of the InSpace System will ultimately enroll up to 45 patients, all of whom will be followed for up to 24 months. The study population consists of elderly patients who are not candidates for surgery under general anesthesia and who did not respond to conservative treatment, including steroid injections and physical therapy. This publication represents a planned interim analysis of the first 15 patients enrolled, who were considered evaluable upon reaching 12 months of follow-up. All 15 patients in this cohort experienced overall improvements in shoulder function, as measured by the Constant Score and the American Shoulder and Elbow Surgeons Evaluation Form (ASES). Of these patients, 85% showed a clinically significant improvement in their Constant Score. Improvements were observed beginning at 6 weeks post treatment and sustained for at least 12 months post-treatment. Additionally, patients reported significant improvements in pain scores.
“We are pleased with these results from Dr. Gervasi and colleagues. These data reinforce and continue to build on the existing data supporting the use of InSpace for patients with massive rotator cuff tears,” said Itay Barnea, CEO of OrthoSpace. “The cases represent an unmet clinical need, and we are proud to offer additional surgical options for patients who are suffering from pain and immobility associated with this difficult indication.”
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 and Israel and has been granted an Investigational Device Exemption (IDE) to initiate a pivotal human clinical study of the InSpace System in the United States.