OrthAlign Partnerships Bring KneeAlign Technology to Japanese, French Markets

OrthAlign Inc.’s knee arthroplasty technology is going global.

The Aliso Viejo, Calif., company has partnered with two orthopedic implant behemoths to distribute its KneeAlign total knee arthroplasty (TKA) technology in Japan and France.

OrthAlign’s partnership with Biomet Japan occurs just months after the Japanese regulators approved the use of KneeAlign in TKA procedures in that country. KneeAlign provides both tibial and distal femoral navigation in a palm-sized, single-use device that is compatible with all implant systems. The company claims the product is accurate for overall mechanical, tibial, and femoral component alignment in TKA, comparing favorably to large-console Computer-Assisted Surgery (CAS) systems.

“We are pleased with the Japanese Ministry’s approval for use of KneeAlign in Japan,” said James Young Kim, OrthAlign’s vice president of Marketing. “There were approximately 70,000 TKAs in Japan during 2013, and this number will likely increase as the population ages, so this is a very important market for us in our international growth strategy. We are thrilled to be partnering with Biomet Japan in providing full access to OrthAlign technology for Japanese surgeons. Ultimately, we hope it helps to raise the standard of care in Japan for TKAs.”

OrthAlign is penetrating the French market through a distribution agreement with Lima France, a subsidiary of global orthopedic implant developer/manufacturer Lima Corporate.

Approximately 45,000 TKAs are performed in France each year, and experts say the market is growing at an annual rate of 10 percent. “In order to better provide our customers with effective technology and to best address the needs of French surgeons, we have chosen OrthAlign’s KneeAlign system as our alignment technology,” said Thierry Cassat, general manager of Lima France. “This system differentiates our product offering in the French marketplace and addresses those immediate needs of our surgeons.”

A recent U.S. study by Denis Nam, M.D., (Washington University, St. Louis, Mo.), found that KneeAlign decreases the incidence of outliers for tibial component alignment in both the coronal and sagittal planes, and improves the surgeon’s ability to achieve a specific, intraoperative goal, compared to conventional, tibial extramedullary (EM) alignment guides in TKA. In the KneeAlign cohort, 95.7 percent of tibial components were within two degrees of perpendicular to the tibial mechanical axis and 95 percent of tibial components were within two degrees of a three-degree posterior slope (compared with 68.1 percent and 72.1 percent in the EM cohort, respectively). This study was conducted as a randomized control trial, consisting of five different surgeons.

Another U.S. study by Nam uncovered significant differences between KneeAlign and computer-assisted surgery (CAS) regarding the accuracy of femoral component alignment, with 94.9 percent of patients in the KneeAlign cohort having an alignment within two degrees of neutral vs. 92.5 percent in the CAS cohort. There also was a significant difference in overall mechanical alignment of the limb, with 92.5 percent of patients within three degrees of a neutral mechanical axis in the KneeAlign cohort vs. 86.3 percent in the CAS cohort. There was no statistically significant difference in tibial component alignment in this study.

“As we continue building on our international growth strategy, France is also a very important country for OrthAlign,” Kim said. “We are thrilled to be partnering with Lima France in providing French surgeons with full access to OrthAlign technology. Ultimately, we hope it helps to raise the standard of care in France for TKAs.”