Only Artificial Cervical Disc that Mimics the Anatomic Structure of a Natural Disc
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Illustration of the M6-C(TM) artificial cervical disc. (Photo: Business Wire)
“With the approval of the M6-C artificial cervical disc, Orthofix now
has the industry’s most comprehensive portfolio of cervical spine
products to best serve our surgeon customers and patients,” said
Orthofix President and Chief Executive Officer,
The M6-C artificial cervical disc is a next-generation artificial disc developed to replace an intervertebral disc damaged by cervical disc degeneration. Designed to restore physiologic motion to the spine, the M6-C disc is indicated as an alternative to cervical fusion. The M6-C artificial cervical disc preserves motion by restoring biomechanical function at the treated level after native disc removal and potentially reduces subsequent degeneration of adjacent vertebral segments. The M6-C device is the only artificial cervical disc that mimics the anatomic structure of a natural disc by incorporating an artificial visco-elastic nucleus and fiber annulus into its design. 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.
Pre-market approval was based on clinical data from a U.S. Investigational Device Exemption (IDE) study that evaluated the safety and effectiveness of the M6-C artificial cervical disc compared to anterior cervical discectomy and fusion (ACDF) for the treatment of symptomatic cervical radiculopathy with or without cord compression. Patients in the study presented with degenerative cervical radiculopathy requiring surgical intervention, and confirmed clinically and radiographically at one vertebral level from C3 to C7.
Study results at 24 months include the following clinical patient outcomes:
- 90.5 percent of patients who received the M6-C disc demonstrated a meaningful clinical improvement in the Neck Disability Index.
- A meaningful clinical improvement in arm pain score was seen in 91.2 percent of the M6-C disc patients compared to 77.9 percent in ACDF patients. In addition, this same meaningful improvement was seen in neck pain scores with 90.5 percent of patients who received the M6-C disc compared to 79.9 percent in patients who underwent the ACDF procedure.
- The M6-C disc preserved range of motion in flexion-extension and lateral bending in the study group.
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,
14.0 percent of the M6-C disc patients were still taking some type of
pain medication compared to 38.2 percent of the ACDF patients.
- Of the patients still taking pain medication there was a seven times higher rate of opioid use with the ACDF patients than with patients who received the M6-C disc.
- Additional 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.
The prospective, non-randomized, concurrently controlled, multi-center
clinical trial was conducted at 23 sites in
“Cervical disc degeneration is a common condition that can cause pain in
the neck, shoulders, arms and hands and lead to numbness and weakness in
the arm or hands. Often this condition is the result of a vertebral disc
that has deteriorated or been damaged due to the natural aging process
or an injury,” said Dr.
Orthofix expects to release 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 Company will conduct a conference call to discuss 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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