ConforMIS Announces Positive Results from Customized iTotal PS Total Knee Replacement Comparative Study
April 12 2017 - 9:09AM
ConforMIS, Inc. (Nasdaq:CFMS), a medical technology company that
offers joint replacement implants customized to fit each patient's
unique anatomy, today announced results from the first study of its
iTotal® PS total knee replacement presented at the 2017 British
Association for Surgery of the Knee (BASK) Annual Meeting.
Researchers at a leading academic institution compared the knee
motion, or kinematics, of patients implanted with a ConforMIS
iTotal PS customized total knee replacement to patients implanted
with an off-the-shelf Zimmer-Biomet NexGen® PS total knee
replacement. Similar to previously reported studies with the
iTotal CR, this study demonstrated that ConforMIS iTotal PS
patients’ knee motion patterns more closely resemble those of a
normal knee than patients’ knee motion patterns with the
traditional, off-the-shelf implant.
When a healthy knee bends, the lateral condyle, or outer portion
of the end of the thigh bone or femur, rolls back on the shin bone
or tibia and rotates externally, towards the outside of the knee.
In this single-center study, financially supported by ConforMIS,
researchers assessed the kinematics of 31 patients (13 patients
with a ConforMIS iTotal PS implant and 18 patients with an
off-the-shelf implant) at least six months after surgery using
advanced real-time mobile x-ray imaging and 2D-3D registration.
Patients who received a ConforMIS iTotal PS demonstrated
greater average range of motion during a deep knee bend (112° vs.
94°*). Additionally, iTotal PS patients saw greater lateral femoral
rollback (11.73mm vs. 4.69mm*), medial translation (2.8mm vs.
1.0mm*) and greater axial rotation (10.85° vs. 7.58°) during deep
knee bend, which is consistent with normal knee motion. (Note: *
indicates statistical significance with p≤0.05)
“All findings from this study suggest that the iTotal PS has the
kinematic and functional benefits that have been demonstrated with
iTotal CR compared with traditional, off-the-shelf implants,” said
William Kurtz, MD, Chief of Orthopedics at St Thomas Hospital in
Nashville, TN and clinical investigator in the study. “Patients
want to return to everyday activities after their recovery and, in
my experience, maintaining normal knee motion is critical to
achieving those goals. I have found that when you alter patients’
normal kinematics, as happens with off-the-shelf implants, there’s
a greater risk that the patient won’t be able to return to their
regular activities.”
In addition, two studies, financially supported by ConforMIS,
were presented at BASK highlighting the variability in femoral and
tibial anatomy which cannot be replicated by off-the-shelf
implants, which are offered in a limited number of shapes and
sizes:
- A retrospective review of 24,042 CT data sets used to design
customized iTotal implants found that 61% of knees exhibited a
distal femoral offset of >1mm. Additionally, 83% exhibited
>2mm of posterior condylar offset. Off-the-shelf implants are
designed with fixed condylar offsets, which are unable to retain
the natural condylar shape of the knee.
- A similar analysis was conducted on tibial implants and found
that the tibial trays were within 2mm or less of symmetrical only
12% of the time, while 22% were found to have asymmetry >5mm.
The authors concluded that tibial trays that are either symmetric
or have a fixed asymmetry based on medio-lateral size, as
off-the-shelf implants do, may face challenges between maintaining
proper rotation and adequate coverage.
“In its first year of release iTotal PS has met our expectations
in terms of surgeon adoption and patient outcomes,” said Mark
Augusti, MBA, Chief Executive Officer and President of ConforMIS.
“Clinical research has demonstrated our implants offer superior
clinical outcomes compared with off-the-shelf implants. We
are committed to continuing investing in the clinical study of our
implants to demonstrate their superior clinical and economic value
for patients, surgeons, hospitals, and payers across the healthcare
continuum.”
About ConforMIS, Inc.
ConforMIS is a medical technology company that uses its
proprietary iFit Image-to-Implant technology platform to develop,
manufacture and sell joint replacement implants that are
individually sized and shaped, or customized, to fit each patient's
unique anatomy. ConforMIS offers a broad line of customized
knee implants and pre-sterilized, single-use instruments delivered
in a single package to the hospital. In clinical studies,
ConforMIS iTotal CR demonstrated superior clinical outcomes,
including better function and greater patient satisfaction,
compared to traditional, off-the-shelf implants. ConforMIS
owns or exclusively in-licenses approximately 450 issued patents
and pending patent applications that cover customized implants and
patient-specific instrumentation for all major joints.
For more information, visit www.conformis.com. To receive
future releases in e-mail alerts, sign up at
http://ir.conformis.com/.
Cautionary Statement Regarding Forward-Looking
Statements
Any statements in this press release about future expectations,
plans and prospects for ConforMIS, including statements about
ConforMIS' clinical strategy, the potential clinical, economic or
other impacts and advantages of using customized implants and the
commercial launch of iTotal PS, as well as other statements
containing the words "anticipate," "believe," "continue," "could,"
"estimate," "expect," "intend," "may," "might," "plan,"
"potential," "predict," "project," "should," "target," "will," or
"would" and similar expressions, constitute forward-looking
statements within the meaning of the safe harbor provisions of The
Private Securities Litigation Reform Act of 1995. We may not
actually achieve the plans, intentions or expectations disclosed in
our forward-looking statements, and you should not place undue
reliance on our forward-looking statements. Actual results or
events could differ materially from the plans, intentions and
expectations disclosed in the forward-looking statements we make as
a result of a variety of risks and uncertainties, including risks
related to our clinical studies and the other risks and
uncertainties described in the "Risk Factors" sections of our
public filings with the Securities and Exchange Commission. In
addition, the forward-looking statements included in this press
release represent ConforMIS's views as of the date hereof.
ConforMIS anticipates that subsequent events and developments may
cause ConforMIS's views to change. However, while ConforMIS may
elect to update these forward-looking statements at some point in
the future, ConforMIS specifically disclaims any obligation to do
so. These forward-looking statements should not be relied upon as
representing ConforMIS's views as of any date subsequent to the
date hereof.
CONTACT:
Media contacts:
Bill Berry
Berry & Company Public Relations
Bberry@berrypr.com
(212) 253-8881
Lynn Granito
Berry & Company Public Relations
Lgranito@berrypr.com
(212) 253-8881
Investor contact
Oksana Bradley
ir@conformis.com
(781) 374-5598
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