Medical Navigation System Achieves CE Marking – and Wins Follow-on Orders
Metronor HQ, 25.02.2016,
Metronor’s orthopedic navigation is now entering clinical trials as a key part of Ortoma AB’s Ortoma Treatment Solution (OTS) after successful development, animal cadaver test and CE certification phases. To support simultaneous clinical trials at several hospitals, Ortoma has placed a follow-on multi-system order with Metronor.
Says Ortoma founder and CEO Matts Andersson: “We are delighted to have reached this stage, and are extremely happy with the feedback our solution has received from the orthopedic community – they are just as keen as we are to get this into operating theaters. Our hip surgery planning tool received CE approval last year, so with the guidance solution now also approved, we can offer the full benefits of computer assisted surgery. The surgeons love the way our solution integrates into – and not tries to replace – their current processes, and we are encouraged to be seen as a quantum leap in practical, usable computer guided surgery. We look forward to the clinical test phase and expect to confirm the excellent results we have achieved when testing on models and animal cadavers.”
Metronor CEO Oeyvind Roetvold concurs: “Qualifying our technology for medical use marks a major milestone for Metronor, and we are very happy that the testing has shown that the navigation system delivers as promised. The small, single camera has proven to minimize obstruction issues common to legacy navigation solutions, and the smart computerized probe has proven to be a flexible and efficient way for the surgeon to add precision guidance to his current best practices. That was always the goal – to make precision guidance part of the surgeon’s tool box, in a well-integrated and practical way. We’re certain clinical trials will further confirm the benefits of our approach, and we will certainly remain committed to supporting Ortoma in providing a new level of surgical precision for hip replacement patients, and in other orthopedic applications.”
Ortoma completed formal CE approval of the Ortoma Guide including the Metronor navigation system on February 23rd, 2016, and initial clinical tests will take place early March 2016. A multi-hospital study will start late spring 2016, by which time the next batch of navigation systems will have been delivered from Metronor.