BELLEVUE, Wash., Sept. 26, 2019 (GLOBE NEWSWIRE) -- CurvaFix, Inc., a developer of medical devices to repair fractures in curved bones, announced the completion of the first surgical procedure using the CurvaFix® Intramedullary Rodscrew to repair a pelvic fracture. The surgery was performed by orthopedic trauma surgeon Kelly Lefaivre, M.D., M.Sc., FRCSC, associate professor at the University of British Columbia, Vancouver, British Columbia, as part of the CurvaFix sponsored RESTORE Clinical Study.
“The first patient, a female with a high energy lateral compression fracture of the pelvic ring, tolerated the surgical procedure well,” said Dr. Lefaivre. “The CurvaFix Rodscrew is the first intramedullary implant to follow the natural curves of the pelvis.
“For the procedure, a rodscrew was implanted inside the bone across the fracture of the ilium,” continued Dr. Lefaivre. “The flexible rodscrew was then locked, making it rigid to hold the fracture reduction during bone healing.”
Pelvic fractures affect more than 150,000 people per year in the U.S.1 Often caused by car accidents or falls, these fractures are among the most serious and technically complex injuries treated by orthopedic trauma surgeons. Current surgical techniques with straight screws can be limited by bone curvature and surgery with bone plates can require lengthy, invasive open procedures.
“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.”
The CurvaFix Rodscrew System received 510(k) clearance from the U.S. Food and Drug Administration (FDA) in the first half of 2019. The company is in the process of expanding the RESTORE Study to U.S. sites before the end of this year.
About CurvaFix, Inc.
CurvaFix, Inc. is a privately held medical device company headquartered in Bellevue, Wash. The idea for the company germinated when the former division head of orthopedic trauma at the University of British Columbia, Clinical Professor Emeritus, Robert Meek, M.D., FRCSC, believed there was a better way to repair pelvic fractures. Today, CurvaFix is developing implantable products to improve fracture repair in curved bones. The company’s first product is the CurvaFix Rodscrew.
CurvaFix is a trademark of CurvaFix, Inc., registered in the U.S.
1 2014 HCUP database Part B Summary Data Files