Conventus Orthopaedic has completed patient enrollment in a clinical study of its Conventus DRS Implant.
The minimally invasive implant uses Conventus DRS technology to stabilize the fractured bone fragments from within the bone and treat common distal radius fractures.
The international multi-center study, which has enrolled 60 patients from six institutions throughout Germany and Switzerland, is designed to demonstrate the safety and efficacy of Conventus DRS Implant.
The study results demonstrated early and consistent healing with expected return to function and low complication rates.
Radiographic evidence also demonstrated that healing across the fracture site of all available patients occurred as early as six weeks, while disabilities of the arm shoulder and hand scores showed functional improvement at 12 weeks.
Klinikum Starnberg orthopaedic surgeon Michael Strassmair said, "We expect to use the insights gained from this study to further understand how this new technology can help patients return rapidly to normal function with fewer complications."
Conventus Orthopaedics CEO Paul Hindrichs said the company’s clinical study validates proof of concept and demonstrates the potential of Conventus DRS technology.
"We are now embarking on a European postmarket clinical investigation to further demonstrate the potential of our technology in treating peri-articular fractures, and preparing for broader regulatory approval and commercial launch," Hindrichs added.
The company said Conventus DRS Implant, which is pending 510(k) clearance by the US Food and Drug Administration, is not yet cleared for distribution in the US.