MAKO Surgical Corp. Showcases Pioneering MAKOplasty(R) Treatment Options for Total Hip Replacement and Partial Knee Resurfacing Surgeries at AAOS 2013 Annual Meeting
Innovative Procedure Uses Robotic Arm Tactile Technology to Assist Surgeons in Achieving a New Level of Accuracy
CHICAGO, March 18, 2013 (GLOBE NEWSWIRE) -- 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.
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.
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