Performed under the guidance of orthopaedic surgeons
"The early results are encouraging, as the data show more accurate component placement, as well as considerably lower self-reported post-operative pain levels out to six weeks," said Dr. Blyth. "The early results suggest that robotic arm assisted UKA with the RIO system greatly enhances the accuracy of implant placement, which can be achieved with only minimal deviation from the pre-operative plan."
Poor implant positioning in UKA is associated with suboptimal functional outcome following surgery1; however, robotic arm technology for UKA provides pre-operative surgical planning for more accurate and minimal bone resection (excision of part of the bone), and intra-operative joint balancing for improved post-operative function and kinematics.
The primary endpoint of the clinical study is to validate the intra-operative implant alignment values recorded by the RIO system and to compare the accuracy of this implant positioning using robotic arm assistance with that achieved using conventional instrumentation in a randomized cohort. Among the secondary endpoints, the trial also examines early post-operative pain, and initial results show a reduction in patient reported post-op pain, which persists for almost 90 days following surgery. This ongoing trial will assess patient clinical, psychological and functional outcomes pre-operatively and at three months, one year, two years, five years and ten-years post-operatively.
"We are very happy with the early results for this randomized clinical trial, as it demonstrates the effectiveness of our RIO system and MAKOplasty® Partial Knee Resurfacing as a minimally invasive surgical option for patients with early to mid-stage osteoarthritis," said Maurice R. Ferré, M.D., president and chief executive officer of MAKO. "Results also suggest that robotic arm assisted surgery for UKA may improve recovery with regard to less pain immediately following the procedure. We believe these early results underscore the importance of accuracy and precision in UKA surgeries, and the benefits that MAKOplasty can provide surgeons and their patients."
MAKO's RIO Robotic Arm Interactive Orthopedic System coupled with its proprietary RESTORIS family of implants, enable surgeons to perform MAKOplasty for knee resurfacing and total hip arthroplasty. The RIO system overcomes limitations of conventional arthroplasty by providing auditory, visual and tactile guidance that, when integrated with the touch and feel of the surgeon's skilled hand, provide consistently reproducible precision in partial knee resurfacing and total hip replacements. This advanced treatment option is designed to relieve pain and restore range of motion for adults living with osteoarthritis and other degenerative hip diseases.
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
"MAKOplasty®," "RESTORIS®," "RIO®," as well as the "MAKO" logo, whether standing alone or in connection with the words "
Oxford® is a registered trademark of Biomet Orthopedics
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