FT. LAUDERDALE, Fla., Sept. 19, 2011 (GLOBE NEWSWIRE) — MAKO Surgical Corp. (Nasdaq:MAKO) today announced the commercial availability of the RIO® Robotic Arm Interactive Orthopedic System for use in total hip replacement procedures, called MAKOplasty® Total Hip Arthroplasty.
MAKO’s total hip replacement application is designed to support the surgeon’s ability to more accurately align and position the implants relative to the needs of a patient. This may reduce potential complications associated with conventional hip replacement surgery. MAKOplasty Total Hip Arthroplasty provides a surgeon with a pre-operative 3-D reconstruction of the patient’s hip and is used to develop the patient-specific surgical plan. The robotic-arm then assists the surgeon during the procedure to accurately prepare the joint and optimally place hip implants.
“MAKOplasty Total Hip Arthroplasty provides a significant advantage to me as a surgeon and to my patients. It provides quantitative knowledge for what were difficult judgment decisions inherent in manually performed operations,” said Lawrence Dorr, M.D., founder and medical director of The Dorr Arthritis Institute in Los Angeles. “When I finish a hip replacement I no longer am anxious to see the x-ray because I know I’ve got the implants, leg length and offset correct. It makes recovery easier for patients, including their comfort, activities and protection from dislocation. This robotic guided operation is better for both me and my patients.”
A recently published Massachusetts General Hospital study reported that, over a sustained period of study of 1,823 hips, only 50 percent of acetabular cups (cup-shaped sockets of the hip joint) were positioned in the acceptable range. Mal-positioning of acetabular cups in conventional hip replacement surgery may lead to impingement that can cause dislocation, fracture, and increased implant wear.1 Nearly 300,000 primary hip replacement surgeries are performed annually in the United States using conventional techniques.
“We’re pleased to introduce MAKOplasty Total Hip Arthroplasty as an option for surgeons who perform total hip replacement,” said Maurice R. Ferrė, M.D., president and chief executive officer of MAKO Surgical Corp. “We believe that surgeons and patients will benefit from a technology that can help improve accuracy and precision in surgery and result in a potential reduction of the complications reported from conventional approaches.”
According to a June 2011 survey conducted by Harris Interactive, six in 10 adults ages 40+ are afraid they will lose their ability to walk and/or move around without pain. Nearly nine out of 10 survey respondents thought that hip replacement gives people back their independence and believe it can restore a better quality of life.2
“With my hip pain, I really couldn’t walk or sleep, and going up and down stairs was very painful,” said Victoria Handy Smudzinski, 44, who has osteoarthritis of the hip and had a total hip replacement with MAKOplasty. “I’m glad that I had the MAKOplasty procedure because already I am on my way back to a normal life.”
Approximately 10 million Americans suffer from osteoarthritis (OA) of the hip, or the wearing away of the cartilage that cushions the bones of the hips, causing hip pain and stiffness, which can affect mobility, including walking and bending. Hip OA is the most common cause of hip replacement surgery.3
MAKOplasty Total Hip Arthroplasty is the newest application for MAKO’s RIO robotic arm system and builds upon five years of MAKO’s existing MAKOplasty Partial Knee Resurfacing procedure for patients with early to mid-stage osteoarthritis of the knee. MAKOplasty Total Hip Arthroplasty was cleared for use in the U.S. by the FDA in February 2010.
About MAKO Surgical Corp.
MAKO Surgical Corp. is a medical device company that markets both its RIO® Robotic-Arm Interactive Orthopedic system and its proprietary RESTORIS® implants for orthopedic knee and hip procedures called MAKOplasty®. The RIO is a surgeon-interactive tactile surgical platform that incorporates a robotic arm and patient-specific visualization technology, which enables precise, consistently reproducible bone resection for the accurate insertion and alignment of MAKO’s RESTORIS implants. The MAKOplasty solution is comprised of 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 competitive conditions and prices in MAKO’s markets, unanticipated issues relating to intended product launches, decreases in sales of MAKO’s principal product lines, increases in expenditures related to increased or changing governmental regulation or taxation of MAKO’s business, unanticipated issues in complying with regulatory requirements related to MAKO’s current products or securing regulatory clearance or approvals for new products or upgrades or changes to MAKO’s current products, the impact of the recently enacted United States healthcare reform legislation on hospital spending, reimbursement, and the taxing of medical device companies, loss of key management and other personnel or inability to attract such management and other personnel 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, 2010 filed on March 10, 2011. 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.
MAKO does and seeks to do engage healthcare professionals and entities in the development and improvement of our products. Our policy statement and roster of healthcare professional partners are available at http://www.makosurgical.com/site/index.php/company/business-conduct-2.
“MAKOplasty®,” “RESTORIS®,” and “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 Clinical Orthopaedics and Related Research. 2011:469(2):319-329.
2 Survey conducted by phone within the United States by Harris Interactive from June 16-June 20, 2011 among 1,631 adults ages 40 and older. Results were weighted to reflect the U.S. adult population.
3 AAOS Website http://orthoinfo.aaos.org/topic.cfm?topic=a00377