The first pelvic fracture repair using the CurvaFix® Intramedullary Rodscrew has occurred in Canada, part of the CurvaFix sponsored RESTORE Clinical Study. The company will expand the study to U.S. sites before the end of 2019.
Pelvic fractures can be the most technically complex injuries treated by trauma surgeons. Current techniques with straight screws can be limited by bone curvature, and surgery with bone plates can require lengthy, invasive open procedures. CurvaFix Rodscrew is the first intramedullary implant to follow the natural curves of the pelvis. The system received FDA 510(k) clearance in 1Q19.
“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.”
Source: CurvaFix, Inc.