SAN JOSE, Calif.--(BUSINESS WIRE)--SpineAlign Medical, Inc. announced today that it has enrolled its initial patient in the European Observational Registry for the VerteLift System, an observation study to further assess the ability of the VerteLift System to treat the pain and dysfunction associated with osteoporotic vertebral compression fractures (VCF), while providing clinically measurable height restoration based upon previous European experience and analysis. On August 30th, Dr. Frank Hassel, Loretto-Hospital, Freiburg Germany surgically treated the first patient in the multi-center observation registry. VerteLift is SpineAlign’s first CE Mark product in commercial release outside the US. It is a transpedicular, minimally invasive approach to reduction, stabilization and pain relief associated with vertebral compression fractures.
“I am very happy to participate in the VerteLift Observational Registry with a number of my colleagues in Germany,” stated Dr. Hassel. “Surgeons treating vertebral compression fractures have always attempted to treat and eliminate debilitating pain resulting from VCF. The ability to predictably restore lost height has been challenging with previous technologies. VerteLift provides the ability to treat the pain of VCF and stabilize spinal fractures, and may also provide predictable clinically significant height restoration due to its unique Nitinol implant design. ”
“We are very excited to have initiated the Observational Registry in Germany with Dr. Hassel in Freiburg,” said Gary Grenter, President & CEO, SpineAlign Medical, Inc. “We are fortunate to be working with a number of outstanding spine specialists, including Dr. Hassel. The VerteLift marks a departure from traditional vertebroplasty and balloon kyphoplasty procedures. We believe our proprietary Nitinol spine implant provides the flexibility height restoration and safety features to deliver an effective treatment for VCF patients.”
“Our goal is to help surgeons achieve optimal vertebral reconstruction,” stated Chris McAuliffe, COO at SpineAlign. “Previous technologies have promised reliable height restoration. The VerteLift implant, we believe, delivers on that promise with proprietary design and specialized materials. Our goals are simple, to exceed surgeon expectations and help improve patient treatment outcomes.”
The VerteLift System represents the first of many new innovations in the area of minimally invasive percutaneous vertebral body reconstructions to come from SpineAlign Medical. The treatment of spine disease is rapidly moving from open surgery toward less tissue disruptive procedures with the use of better imaging and innovative, minimally invasive devices.
The VerteLift System represents the first of many new innovations in the area of minimally invasive percutaneous vertebral body reconstruction and augmentation to be developed by SpineAlign Medical. The VerteLift System is a vertebral body implant designed to treat vertebral compression fractures in the thoracic or lumbar spine, most commonly occurring in patients suffering from osteoporosis. The VerteLift Implant is an expandable metal device made from nickel-titanium (Nitinol) alloy that provides internal scaffolding to engage the vertebral body endplates, while providing and maintaining lift until bone cement is injected. VerteLift System is available in two shapes and a range of sizes to address different anatomical needs for the treatment of vertebral compression fractures. Prior to injection of bone cement, the VerteLift Implant is fully retrievable. SpineAlign products have CE approval and are commercially available in the European Union. The VerteLift System is not yet commercially available in the United States but is currently in clinical evaluation to support a 510(k) submission with the FDA.
SpineAlign Medical, Inc., is an early-stage commercial medical device company dedicated to the design, development and successful commercialization of minimally-invasive products for spine procedures.