DFine has received medical device license from Health Canada and the Secretaria de Salud (Ministry of Health) in Mexico to sell its StabiliT Radiofrequency Targeted Vertebral Augmentation (RF-TVA) system throughout Canada and Mexico, respectively.
“StabiliT represents a significant advance in the treatment of osteoporotic compression fractures. The ability to target access and cement delivery while sparing valuable cancellous bone in patients who already have compromised bone structure due to osteoporosis is significant. I am very pleased that we will now have access to this technology in Canada,” said Kieran Murphy, deputy chief of radiology at University Health Network, Toronto, Canada.
“Approvals in Canada and Mexico are significant milestones for DFine and the StabiliT system. With the North American market established, we will continue to execute our broader global expansion strategy, which will focus on potential growth markets including South America, Asia Pacific and the Middle East,” said Kevin Mosher, chief executive officer of DFine.
With StabiliT, physicians are able to navigate within the vertebral body to target the spinal fracture with greater precision and control, while also sparing the bone— two unique benefits of RF-TVA over older, conventional therapies such as balloon kyphoplasty. The RF-TVA procedure typically takes 30−40 minutes to complete under local anesthesia. Patients report significant and lasting back pain relief, significant improvement in mobility and quality of life, and often return to daily activities soon after the procedure.
DFine received FDA’s 510(k) clearance and commercially introduced the StabiliT system in 2008. To date, more than 12,000 spinal fractures have been treated with StabiliT worldwide.