Medical Device Daily Executive Editor

The premise behind MAKO Surgical's (Fort Lauderdale, Florida) approach to minimally invasive knee procedures is simple: What you plan is what you get.

And that's what the company highlighted at last week's annual conference of the American Academy of Orthopaedic Surgeons (AAOS; Rosemont, Illinois), where it debuted its RIO Robotic Arm Interactive Orthopedic System and Restoris MCK MultiCompartmental Knee System after receiving FDA clearance of the products in December.

Maurice Ferré, MD, president/CEO/chairman of the company, ebulliently told Medical Device Daily that the AAOS gathering "was kind of our 'coming out' party."

Ferré said the traffic at MAKO's booth on the exhibit floor was constant. "We have taken the floor by storm," he said in a phone interview from that busy exhibit area. "We're kind of the talk of the town."

Asked how surgeons were reacting to the new systems being exhibited by the company, Ferré said, "When they put their hands on the robot, they have an epiphany."

He said the RIO system's passive robotic arm means "you can truly introduce minimally invasive surgery" to the knee-replacement sector.

Ferré said that for unicompartmental and bicompartmental knee systems, "you need perfect placement," and that's what RIO and the Restoris implants provide. He described Restoris as "the first robotic-enabled implants, specifically designed to be put in with a robotic system."

The RIO system provides patient-specific, 3-D modeling for pre-surgical planning. "As surgeons use the robotic arm to resurface the knee for placement of the implants," the company said in a statement, "RIO provides real-time, inter-operative visual, tactile and auditory feedback, enabling a high level of precision and optimal positioning of the implants."

MAKOplasty makes partial knee resurfacing available to a larger patient population. It previously was only possible to perform such resurfacing on the inner, or medial, portion of the knee. With the RIO system and Restoris MCK components, it now can be performed on both the medial and patellofemoral, or top, portion of the knee.

MAKO is well-positioned to gain serious traction in a space dominated by such big players as DePuy (Warsaw, Indiana), Stryker (Kalamazoo, Michigan), Smith & Nephew Orthopaedics (Memphis, Tennessee) and Zimmer (also Warsaw).

"We hold the key patents in orthopedic robotics," said Ferré. The company's IP portfolio includes more than 250 licensed or owned patents and patent applications relating to computer-assisted surgery, haptics, robotics and implants.

Declaring that robotics "has come of age," he said MAKO thinks it can address fully 50% of the existing total knee replacement (TKR) market. That's especially true, Ferré said, given today's economic travails. "With the kind of resurfacing approach we offer, the recovery period is much shorter," so patients undergoing a MAKOplasty procedure miss less work.

He noted that one of the difficulties in building clinician interest in minimally invasive approaches is that unicompartmental procedures are difficult to do, "but now, with robotics, they can do it."

Ferré likened the process to a paint-by-numbers project. "Via CT [computed tomography], the clinician creates 'virtual walls' you have borders, and this keeps you from drawing or painting outside the lines."

He said that the orthopedic sector has seen "a lot of progress with materials and implant design, but not a lot of progress in terms of delivery systems."

Enter the RIO System, which Ferré said targets a market of 15 million persons with osteoarthritis of the knee. Of that market, only 10% currently are done as unicompartmental procedures. "We feel we can address 350,000 procedures," he said.

"We think in particular of those over 70," who are reluctant to face knee replacement surgery, he said. "Now, here's an implant that won't be as difficult for them to endure the rehabilitation. That's a great patient population for us."

The company has come a long way in a relatively short period of time. It was founded in November 2004 and received clearance for the first version of its Tactile Guidance System (TGS) a year later. Two enhanced versions of TGS were released in 2008, then came the Restoris Unicompartmental Knee System, cleared by the FDA last June.

December 2008 brought approval of the second-generation robotic system, the RIO, along with the Restoris MCK.

As of year-end 2008, a total of 782 MAKOplasty procedures had been conducted, with 17 sites up and running. "We have two years worth of data on some cases," Ferré said, and seven journal articles have just been accepted for publication.

Seven of those studies were reported in the February issue of The American Journal of Orthopedics.

Among the authors was Martin Roche, MD, chief of orthopedic surgery at Holy Cross Hospital (Fort Lauderdale), who performed the first MAKOplasty procedure back in June 2006 and has been a big fan of the approach since he first learned of the company from "one of the financial guys" who had left the hospital to join the fledgling firm.

"We were their first site to do MAKOplasty," he said, adding that the procedure "gives results" for both clinicians and patients. He noted that patients "go home much quicker" than with conventional knee replacement approaches.

"I look on it as a very smart software system that lets me put in a knee that I can micro-adjust in order to put it in perfectly," Roche said. "What I plan is what I consistently get."

He has now done about 180 MAKOplasty procedures, including doing his first bi-compartmental knee procedure with the RIO system in January, and says the new system and new knees from MAKO likely will mean he'll increase his percentage of knee replacement procedures done via MAKOplasty from 10% to 20% of the total.

Roche said patients are "very excited" about the concept of doing their procedures robotically, seeing it as an advancement of technique that can improve their respective outcomes.

Poised for gains in a crowded knee-replacement market, the company has had success in the financial markets, raising $91 million last year from an IPO in February and a private placement in October.

"We've seen this coming," Ferré declared. "The future is all about precision surgery and the use of robotics."

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