SAN JOSE, Calif.–(BUSINESS WIRE)–SpineAlign Medical, Inc. (formerly SpineWorks Medical, Inc.) announced today the successful treatment of the first patient in its FDA Investigational Device Exemption (IDE) feasibility study. The SpineAlign System is designed for the treatment of vertebral compression fractures and features an innovative nitinol implant designed to achieve vertebral body reconstruction via a transpedicular, minimally-invasive approach.
“We had an excellent outcome with the SpineAlign device – the patient’s pain scores dropped dramatically within 24 hours and we achieved good central fracture reduction,” said Bohdan Chopko, M.D., Ph.D., clinical faculty member at Northeastern Ohio Universities College of Medicine and practicing neurosurgeon at Mid-Ohio Neurosurgical Care, Mansfield, Ohio. “Both my patient and I were excited to participate in the U.S. introduction of this cutting edge technology. The SpineAlign System shows great promise for the treatment of vertebral compression fractures and the restoration of vertebral anatomy.”
“We are very pleased to have achieved this major milestone, which marks the initial phase of our clinical program in the United States,” said Paul Chirico, President and CEO of SpineAlign Medical. “Combined with the product’s successful commercial debut in Rome two weeks ago at the ASSR/ESNR joint conference, the clinical introduction of the product in the U.S. demonstrates that the company’s momentum is beginning to build.”