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Safe Market Release - MatOrtho Approach Highlighted at AOA ASM 2016

Safe Market Release - MatOrtho Approach Highlighted at AOA ASM 2016

Tuesday, December 20, 2016

A/Prof. Bill Walter (Mater Hospital, Sydney) took the time to describe the approach to market introduction that MatOrtho® is committed to at this year's AOA and NZOA combined meeting in Cairns. He compared it to the “Stepwise Innovation‟ concept by Henrik Malchau in 1995(1), and called it “Super-stepwise Innovation‟.

Since achieving CE approval, the SAIPH® Knee has been subject to multilayer studies to build evidence as it is released to more surgeons and hospitals and an increasing number of patients. Steps have included high-precision metrics(2), developing surgeons’ multicentre study, a non-developing surgeons’ multicentre study combined with individual surgeon RCT and a growing platform of registry data.

Professor FS Haddad also commented on the studies based around the SAIPH® Knee to build the evidence base on the design with “robust data”, and challenged others to think of another implant that has been introduced in the last couple of decades that has been through such a “rigorous, sensible process” to market entry.

This approach is supported by the excellent results that are being reported for the SAIPH® Knee.

1.    Malchau H. On the importance of stepwise introduction of new implant technology. PhD Thesis, University of Gothenburg, 1995.
2.    Shimmin A, Martinez Martos S, Owens J, Iorgulescu AD, Banks S. Fluoroscopic motion study confirming the stability of a medial pivot design total knee arthroplasty. The Knee. 2015; 22 

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