Orthofix's artificial cervical disc received FDA 510(k) approval.
Five things to know:
1. The M6-C cervical disc, which Orthofix acquired when it purchased Spinal Kinetics in April 2018, earned FDA approval in February. "The launch of the M6-C artificial cervical disc in the U.S. will complement this existing spine portfolio and represents a significant milestone in the execution of our strategy to accelerate topline growth," said Orthofix President and CEO Brad Mason.
2. The next-generation artificial disc technology was designed to restore physiologic motion of the spine, mimicking the natural anatomical structure of the spine with an artificial visco-elastic nucleus and fiber annulus incorporated into the disc.
3. In a study evaluating M6-C compared to anterior cervical discectomy and fusion, the company reported 24-month results including:
• Meaningful clinical improvement in Neck Disability Index scores for 90.5 percent of disc replacement patients.
• Meaningful clinical improvement in arm pain scores in 91.2 percent of artificial disc patients, compared with 77.9 percent in fusion patients.
• Drop from 80.6 percent of patients on pain medication before surgery to 14 percent 24 months after surgery in the artificial disc group.
By comparison, 85.7 percent of the fusion group patients took pain medication before surgery and 38.2 percent were still taking pain medication 24 months after surgery.
4. The study reported 1.9 percent of the M6-C patients needed additional surgery at the treated level, compared to 4.8 percent of fusion patients.
5. Orthofix expects to have a controlled, limited market release in the U.S. during 2019, and offer extensive surgeon training and education in the technology. Since the M6-C earned the CE Mark in Europe in 2014, there have been more than 45,000 implantations.