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In March of this year, CurvaFix, a developer of medical devices to repair bone fractures in orthopedic trauma patients, received FDA approval for its CurvaFix Intramedullary Rodscrew. Six months later, through the sponsored RESTORE clinical study, the device was successfully used for the first time to repair a patient’s pelvic fracture.
The surgeon performing the procedure during the clinical study was orthopedic trauma surgeon, Kelly Lefaivre, M.D., M.Sc., FRCSC, associate professor at the University of British Columbia. Dr. Lafaivre stated that “for the procedure, a rodscrew was implanted inside the bone across the fracture of the ilium. The flexible rodscrew was then locked, making it rigid to hold the fracture reduction during bone healing.” Dr. Lafaivre added that “the first patient, a female with a high energy lateral compression fracture of the pelvic ring, tolerated the surgical procedure well. The CurvaFix Rodscrew is the first intramedullary implant to follow the natural curves of the pelvis.”
When analyzing the orthopedic trauma market, iData Research found that there has been an emphasis on treating hip fractures with intramedullary screws instead of conventional hip screws and sliding plates. There is a decreased amount of operative blood loss and, accordingly, a shorter hospital treatment with these devices. Surgeons value the stability, rigidity and reliability offered by intramedullary hip screws. While the CurvaFix Intramedullary Rodscrew is minimally invasive, and follows the natural shape of curved bones like the pelvis, the device carries a higher average selling price (ASP). The device can expect to positively contribute to the value of the intramedullary hip screw segment of the overall market.
“The RESTORE study is focused on gathering clinical evidence supporting the Rodscrew System’s potential benefits for pelvic fracture patients in advance of our U.S. commercial launch in 2020,” said Steve Dimmer, chief executive officer of CurvaFix. “The treatment of the first patient in Canada under a Health Canada Investigational Testing Authorization (ITA) is an important milestone as we work to restore mobility for pelvic trauma patients with our novel implantable device.”
For Further Information
To get in an in-depth market overview, as well as insight through primary research and procedural volumes from 19 countries, please read iData Research’s’ 2863 page Trauma Devices Market Analysis, Size, and Trends Report.