MAKO Surgical Corp. (Nasdaq:MAKO), the leader in robotic arm
assisted partial knee and total hip arthroplasty worldwide, today
announced that it will showcase its MAKOplasty® Total Hip
Arthroplasty (THA) and Partial Knee Resurfacing applications at the
American Academy of Orthopaedic Surgeons 2013 Annual Meeting
(AAOS), March 20-23 at McCormick Place in Chicago. During the
meeting, orthopedic surgeons will deliver presentations and provide
hands-on demonstrations in MAKO's booth #212.
MAKOplasty THA is the company's latest application for its RIO®
Robotic Arm Interactive Orthopedic System, which will be
highlighted by the company during the meeting. The RIO system
overcomes limitations of conventional arthroplasty surgeries by
providing auditory, visual and tactile guidance that, when
integrated with the touch and feel of the surgeon's skilled hand,
provides consistently reproducible precision in total hip and
partial knee surgeries. MAKO's robotic arm assisted THA may result
in a reduction in complications associated with conventional hip
replacement surgery.
"With total hip replacement using MAKO robotic-arm assistance, I
am a better surgeon because I perform 95 percent of my operations
with the implants always in the correct position," said Lawrence
Dorr, M.D., clinical professor of orthopedics at Keck School of
Medicine at University of Southern California in Los Angeles. "This
is better than the Harvard data, which showed 47 percent of the
implants in the correct position1. Even in my own practice, the
MAKO robotic-arm assistance provides me with greater precision
compared to when I perform the hip replacement using my experience
only. Every patient who comes to me expects me to give him or her a
precise operation. My consistent results allow me to fulfill the
trust the patient puts in me," said Dr. Dorr.
"Knowing I have an accurate hip reconstruction gives me
confidence I have minimized the risks for impingement and its
consequent complications of dislocation, pain and accelerated wear.
I also believe I have optimized the chance for durability of the
hip replacement of 30 years," continued Dr. Dorr.
Hip replacement with MAKO's robotic-arm assistance builds upon
the proven benefits of MAKOplasty Partial Knee Resurfacing,
developed as an advanced treatment option designed to relieve pain
for adults living with early to mid-stage osteoarthritis that has
not yet spread to all three compartments of the knee. The use of
the RIO system in MAKOplasty partial knee resurfacing leads to
implant component placement that is two to three times more
accurate than manual techniques2. Studies also show that patients
with bicompartmental MAKOplasty have improved function over those
with total knee replacement surgery, and that these MAKOplasty
patients demonstrate better post-operative range of motion and
quadriceps strength compared to total knee arthroplasty3.
"The MAKOplasty procedure with the RIO system for THA and
partial knee resurfacing not only improves accuracy and
reproducibility in surgery, it improves my patients' recovery,"
said Robert C. Marchand, M.D., a partner at South County
Orthopedics in Wakefield, R.I., and one of the presenters in MAKO's
booth during the AAOS 2013 Annual Meeting. "With partial knee
resurfacing for example, I am able to use the RIO system to create
an anatomical model of the patient's knee and develop a patient
specific plan for optimal implant positioning based on the
patient's individual anatomy. The RIO provides feedback and
guidance, thereby preventing me from removing bone form outside the
specified plan, and it allows for accurate implant placement. Our
patients recover more quickly compared to conventional techniques
and their post-operative range of motion is improved as well."
Additional studies describing the clinical success using MAKO's
RIO system and its RESTORIS® family of implants when performing
MAKOplasty procedures are beginning to appear in peer-reviewed
journals, and a body of growing clinical data continues to be
presented at academic meetings worldwide. In a recent oral
presentation of a multi-center trial, the authors presented key
results regarding the accuracy of robotic arm cup placement in
total hip procedures, and reported 87 percent were positioned in an
acceptable range. This compares favorably to data from a recently
published Massachusetts General Hospital (MGH) study, which
evaluated 1,823 hips receiving manual total hip arthroplasty, which
reported 47 percent of cups were placed in an acceptable rage.
Mal-positioning of acetabular cups in conventional hip replacement
surgery may lead to impingement and implant wear that can cause
dislocation4. Nearly 300,000 primary hip replacement surgeries are
performed annually in the United States using conventional
technique.
Another multi-center study of MAKOplasty partial knee cases
using RESTORIS MCK onlay medial unicompartmental implants, found
very low two year post-operative revision rates of 0.4 percent,
compared to two year revision rates reported at 4.0 percent and 4.4
percent respectively in the Swedish and Australian registries5.
As of December 31, 2012, approximately 23,000 MAKOplasty
procedures have been performed worldwide.
About MAKO Surgical Corp.
MAKO Surgical Corp. is a medical device company that
markets its RIO® Robotic-Arm Interactive Orthopedic system, with
specific applications for partial knee resurfacing and total hip
replacement, and proprietary RESTORIS® Family of Implants for
orthopedic procedures called MAKOplasty®. The RIO is a
surgeon-interactive tactile surgical platform that incorporates a
robotic arm and patient-specific visualization technology, which
enables accurate, consistently reproducible bone resection for
accurate insertion and alignment of RESTORIS knee and hip implants.
The MAKOplasty solution incorporates technologies enabled by an
intellectual property portfolio including more than 300 U.S. and
foreign, owned and licensed, patents and patent applications.
Additional information can be found at www.makosurgical.com.
Forward-Looking Statements
This press release contains forward-looking statements
regarding, among other things, statements related to expectations,
goals, plans, objectives and future events. MAKO intends such
forward-looking statements to be covered by the safe harbor
provisions for forward-looking statements contained in Section 21E
of the Securities Exchange Act of 1934 and the Private Securities
Reform Act of 1995. In some cases, forward-looking statements can
be identified by the following words: "may," "will," "could,"
"would," "should," "expect," "intend," "plan," "anticipate,"
"believe," "estimate," "predict," "project," "potential,"
"continue," "ongoing," or the negative of these terms or other
comparable terminology, although not all forward-looking statements
contain these words. These statements are based on the current
estimates and assumptions of our management as of the date of this
press release and are subject to risks, uncertainties, changes in
circumstances, assumptions and other factors that may cause actual
results to differ materially from those indicated by
forward-looking statements, many of which are beyond MAKO's ability
to control or predict. Such factors, among others, may have a
material adverse effect on MAKO's business, financial condition and
results of operations and may include the potentially significant
impact of a continued economic downturn or delayed economic
recovery on the ability of MAKO's customers to secure adequate
funding, including access to credit, for the purchase of MAKO's
products or cause MAKO's customers to delay a purchasing decision,
changes in general economic conditions and credit conditions,
changes in the availability of capital and financing sources for
our company and our customers, unanticipated changes in the timing
of the sales cycle for MAKO's products or the vetting process
undertaken by prospective customers, changes in competitive
conditions and prices in MAKO's markets, changes in the
relationship between supply of and demand for our products,
fluctuations in costs and availability of raw materials and labor,
changes in other significant operating expenses, slowdowns, delays,
or inefficiencies in MAKO's product research and development
cycles, unanticipated issues relating to intended product launches,
decreases in sales of MAKO's principal product lines, decreases in
utilization of MAKO's principal product lines or in procedure
volume, increases in expenditures related to increased or changing
governmental regulation or taxation of MAKO's business, both
nationally and internationally, unanticipated issues in complying
with domestic or foreign regulatory requirements related to MAKO's
current products, including initiating and communicating product
actions or product recalls and meeting Medical Device Reporting
requirements and other required reporting to the United States Food
and Drug Administration, or securing regulatory clearance or
approvals for new products or upgrades or changes to MAKO's current
products, developments adversely affecting our potential sales
activities outside the United States, increases in cost containment
efforts by group purchasing organizations, the impact of the United
States healthcare reform legislation enacted in March 2010 on
hospital spending, reimbursement, unanticipated changes in
reimbursement to our customers for our products, and the taxing of
medical device companies, any unanticipated impact arising out of
the securities class action or any other litigation, inquiry, or
investigation brought against MAKO, loss of key management and
other personnel or inability to attract such management and other
personnel, increases in costs of retaining a direct sales force and
building a distributor network, unanticipated issues related to, or
unanticipated changes in or difficulties associated with, the
recruitment of agents and distributors of our products, and
unanticipated intellectual property expenditures required to
develop, market, and defend MAKO's products. These and other risks
are described in greater detail under Item 1A, "Risk Factors," in
MAKO's periodic filings with the Securities and Exchange
Commission, including MAKO's annual report on Form 10-K for the
year ended December 31, 2012 filed on February 28, 2013. Given
these uncertainties, undue reliance should not be placed on these
forward-looking statements. MAKO does not undertake any obligation
to release any revisions to these forward-looking statements
publicly to reflect events or circumstances after the date of this
press release or to reflect the occurrence of unanticipated
events.
"MAKOplasty®," "RESTORIS®," "RIO®," as well as the "MAKO" logo,
whether standing alone or in connection with the words "MAKO
Surgical Corp." are trademarks of MAKO Surgical Corp.
1 Callanan MC, Jarrett B, Bragdon CR, Zurakowski D, Rubash HE,
Freiberg AA, Malchau H. The John Charley Award: Risk factors for
cup malpositioning: Quality improvement through a joint registry at
a tertiary hospital. Clin Orthop Relat Res.
2011;469(2):319-329.
2 Dunbar NJ, Pearle AD, Kenoff D, Conditt M, Banks S. Is UKA
more accurate with robotic assistance? 56th Orthopedic Research
Society Annual Meeting, March 6-9 2010. New Orleans, LA.
3 Kreuzer S, Conditt M, Jones J, Dalal S, Pourmoghaddam A
Functional recovery after bicompartmental arthroplasty, navigated
TKA, and traditional TKA. 25th Annual Congress of ISTA, October
3-6, 2012, Sydney, Australia.
4 Clinical Orthopaedics and Related Research.
2011:469(2)319-329.
5 Roche MW, Coon T, Pearle AD, Dounchis J. Two year
survivorship of robotically guided medial MCK onlay. 25th Annual
Congress of ISTA, October 3-6, 2012, Sydney, Australia.
CONTACT: Media Contacts:
Amy Cook
925.552.7893
amycook@amcpublicrelations.com
Sue Siebert
954.628.0804
ssiebert@makosurgical.com
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