Presented for the First Time during ISASS, Data also Shows Reduction in Pain and Opioid Medication Use
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The Orthofix M6-C™ artificial cervical disc is a next-generation artificial disc developed to replace an intervertebral disc damaged by cervical disc degeneration. The M6-C disc is designed to restore motion to the spine and is an alternative to cervical fusion. (Photo: Business Wire)
The data demonstrates that patients treated with the M6-C artificial cervical disc had significant improvements in neck and arm pain, function and quality of life scores. Additionally, these patients had a significant difference in the reduction of pain and opioid medications use when compared to anterior cervical discectomy and fusion (ACDF) patients. At 24 months, patients in the ACDF group who were still using pain medications had a seven times higher rate of opioid use than those in the M6-C disc group.
“The results from the M6-C artificial cervical disc IDE clinical study continue to validate the positive outcomes of cervical disc arthroplasty versus discectomy with fusion,” said Zigler. “A significant reduction in pain, the maintenance or improvement of neurological function, and the preservation of natural disc motion after 24 months were all meaningful clinical benefits the M6-C disc patients experienced when compared to the fusion control. Additionally, patients receiving the M6-C disc were able to significantly lower their use of NSAIDs – and more importantly – significantly lower their use of opioid medications.”
A prospective, non-randomized, concurrently controlled clinical trial,
the M6-C IDE study was conducted at 23 sites in
Secondary outcomes at 24 months include:
- Patients who received the M6-C disc demonstrated statistically significant improvement in the Neck Disability Index as measured at week six and months three, six, 12 and 24.
Meaningful clinical improvement was seen in the following pain scores:
- 91.2 percent of patients who received the M6-C disc reported an improvement in neck pain compared to 77.9 percent in patients who underwent the ACDF procedure.
- 90.5 percent of the M6-C patients reported improvement in arm pain scores compared to 79.9 percent in ACDF patients.
Prior to surgery, 80.6 percent of the M6-C disc patients and 85.7
percent of the ACDF patients were taking some type of pain medication
for the treatment of their cervical spine condition. At 24 months, the
rate of M6-C patients who were still taking some type of pain
medication dropped to 14.0 percent compared to 38.2 percent of the
- Of these, there was a seven times higher rate of opioid use with the ACDF patients than with patients who received the M6-C disc.
- There was a statistically significant difference in the average mean surgery time – 74.5 minutes for patients receiving the M6-C disc versus 120.2 minutes for those patients having the ACDF procedure.
- In addition, there was a statistically significant difference in the mean length of hospital stay – 0.61 days for the M6-C patients versus 1.10 days for ACDF patients.
- Subsequent surgery at the treated level was needed in 4.8 percent of the ACDF patients compared to 1.9 percent of the M6-C disc patients.
- There were no device migrations reported in the study.
- Overall patients receiving the M6-C disc reported a 92-percent satisfaction rate with the surgery, and 93 percent said they would have the surgery again.
- There were 3.8 percent serious adverse events related to the device or procedure in the M6-C disc group versus 6.1 percent in the ACDF group.
The M6-C disc received
“With the recent
About the M6-C Artificial Cervical Disc
The M6-C artificial cervical disc is a next-generation intervertebral disc designed to restore physiologic motion to the spine and is indicated as an alternative to cervical fusion. The device is comprised of ultra-high molecular weight polyethylene fiber wrapped in a specific pattern, with multiple redundant layers that create a fiber matrix (artificial annulus). The fiber is then wound around a polycarbonate urethane polymer core creating an artificial nucleus. Like a natural disc, this unique construct allows for shock absorption at the implanted level, as well as provides a controlled range of motion when the spine transitions in its combined complex movements.
Orthofix is releasing the M6-C artificial cervical disc in 2019 through a controlled, limited market launch in the U.S. accompanied by an extensive training and education curriculum for surgeons.
The M6-C artificial cervical disc received CE Mark approval for
distribution in the
This communication contains forward-looking statements within the
meaning of Section 21E of the Securities Exchange Act of 1934, as
amended (“the Exchange Act”), and Section 27A of the Securities Act of
1933, as amended, which are based on our current beliefs, assumptions,
expectations, estimates, forecasts and projections. These
forward-looking statements involve risks, uncertainties, assumptions and
other factors which, if they do not materialize or prove correct, could
cause Orthofix’s results to differ materially from historical results or
those expressed or implied by such forward-looking statements.
Therefore, our actual outcomes and results may differ materially from
those expressed in these forward-looking statements. In some cases, you
can identify forward-looking statements by terminology such as “may,”
“will,” “should,” “expects,” “plans,” “anticipates,” “believes,”
“estimates,” “projects,” “intends,” “predicts,” “potential,” or
“continue” or other comparable terminology. The potential risks and
uncertainties that could cause actual growth and results to differ
materially include, but are not limited to: the risk that spine surgeons
may be slow to adopt the M6-C artificial cervical disc; the risk that
future patient studies or clinical experience and data may indicate that
treatment with the M6-C artificial cervical disc does not improve
patient outcomes, or otherwise call into question the benefits of its
use to patients, hospitals and surgeons; the risk that the product may
not perform as intended and may therefore not achieve commercial
success; the risk that competitors may develop superior products or may
have a greater market position enabling more successful
commercialization; the risk that insurance payers may refuse to
reimburse healthcare providers for the use of our products; and other
risks and uncertainties more fully described in Orthofix’s periodic
filings with the
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