Orthofix (NSDQ:OFIX) said today it won regulatory approval from the Japanese Ministry of Health, Labor and Wellfare for its Phoenix minimally invasive spinal fixation system.
The Phoenix system allows for the percutaneous placement of pedicle screws designed to provide stabilization and correction for spinal fusion patients suffering from degenerative disc disease and other conditions, the company said.
“The Japanese approval and full market launch of the Phoenix MIS fixation system represents an important step towards broadening the availability of our spine fixation products globally by entering the 2nd largest spine market in the world. We are committed to continuing to work towards securing additional product approvals in order to provide surgeons in Japan with a full range of our spine fixation solutions,” Orthofix spine fixation prez Ray Fujikawa said in a press release.
Orthofix said the estimated spinal fusion market in Japan will be approximately $684 million by 2020, and that the initial release of Phoenix will “set the stage” for the company to bring more spinal tech to the country in the future.
Yesterday, Orthofix announced the publication of a 12-month study which examined the use of its Trinity Evolution cellular bone allograft in patients undergoing vertebral fusions, touting a greater than 90% fusion rate at 12 months
The study was published in the European Spine Journal, Lewisville, Texas-based Orthofix said.
The study evaluated the use of the Trinity Evolution, in combination with a PEEK interbody spacer and supplemental anterior fixation, for single level fusions at the vertebral locations between C3/C4 and C6/C7, the company said.
