San Jose, CA – 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.”
Since receiving the CE Mark in the fall of 2008, SpineAlign Medical has successfully treated more than 50 patients at several centers of excellence in Europe, and is beginning an aggressive EU commercial launch.
The SpineAlign device represents the first of many new innovations in the area of minimally invasive percutaneous vertebral body reconstruction to come from SpineAlign Medical. The SpineAlign device is a vertebral body implant designed to treat fractures in the thoracic or lumbar spine in patients suffering from osteoporosis. The SpineAlign Implant is an expandable metal device composed of a nickel-titanium (Nitinol) alloy that provides internal scaffolding to engage the vertebral body endplates, maintaining lift until bone cement is injected. SpineAlign is available in two shapes and a range of sizes to address different anatomical needs for the treatment of vertebral compression fractures. Bone cement provides the long-term load bearing support. Prior to injection of bone cement, the SpineAlign Implant is fully retrievable for repositioning or complete removal. The SpineAlign device is not yet available for sale in the United States and is currently in clinical evaluation to support its 510(k) filing with the FDA.
SpineAlign Medical, Inc., is an early-stage medical device company dedicated to the design, development and successful commercialization of minimally-invasive products for spine procedures.