Since the Da Vinci surgical robot made its mark at the turn of the millennium, additional medtech companies have turned their attention to advanced-technology surgical systems and tools--with support from FDA and CMS.
The slow but inevitable--and now quickening--trend toward more automated and robotically assisted surgeries began in earnest in 2000, with the launch of Intuitive Surgical's Da Vinci system, the first such system approved by FDA. Da Vinci, used for soft-tissue surgeries, features robotic arms that reach inside the human body, carrying out movements a surgeon makes on external controls. It is in use in major surgical centers and hospitals in the United States, Western Europe, and elsewhere.
Newer Entries: Mako and Navio
Since Da Vinci's debut, both Stryker and Smith & Nephew have carried on the innovation begun by Intuitive Surgical, launching their own Mako and Navio systems, respectively. The former, the Mako robotic arm, has been on the market for 10 years, with about 300 units sold and used for orthopedic surgeries within the United States during that time. To Stryker's advantage, the Mako just recently earned the regulatory green light for performing total-knee replacement surgery. (It previously was approved for partial-knee-replacement surgery only.) Stryker expects sales of the system, which features a robotic arm that the physician grasps and directs to the hip or knee joint being replaced, to increase in 2017, now that total knee replacements are approved and public acceptance of robotically assisted surgery technology has increased.
Smith & Nephew's Navio is a newer market entry, designed by Blue Belt Technologies and acquired by Smith & Nephew in late 2015. The Navio, like the Mako, performs total-knee-replacement procedures, but the Navio's surgical instrument is contained in a hand-held cutting tool led by precision guidance. The system automatically pauses the motion of the cutting tool if the surgeon moves it beyond the intended area. Seventy-five of the half-million-dollar systems are in use in the United States, including one at the St. Cloud (Minnesota) Surgical Center, where a patient named Vicki Woods got the state's first robotic total-knee replacement in August. The makers of both the Navio and the Mako claim better implant alignment and longer implant life over conventional open surgeries. The systems are intended to provide the least-invasive surgery available.
Beyond Mako and Navio, other digital, sensor-based, and robotic surgical systems and tools are joining the movement. Chicago-based Briteseed's Safesnips are one such technology. Briteseed's low-cost optical sensors integrate directly into the jaws of surgical dissectors and energy tools, providing real-time information back to surgeons. Another, the Mazor Robotics Renaissance Guidance System, is intended to improve outcomes in such spine procedures as degenerative repair, pedicle screw fixation for complex spinal deformity, and vertebral augmentation. Additionally, corporate heavy-hitters Johnson & Johnson and Google have jointly funded a company, Verb Surgical, whose goals include creating "a future unimagined even a few years ago, which will involve machine learning, robotic surgery, instrumentation, advanced visualization, and data analytics," according to the Verb Surgical website.
Both Medicare and medical device companies have forecast that demand for total-knee surgery will grow significantly as members of the baby-boomer generation move into their retirement years. Perhaps with this prediction in mind, the outpatient advisory panel for the federal Center for Medicare and Medicaid Services recommended this summer that Medicare start covering total-knee replacement surgery in same-day surgery centers, instead of just covering the procedure with overnight hospital stays--a move that is likely to benefit marketers of robotically assisted surgery devices, which are increasingly being placed in outpatient surgery centers.
Maureen Kingsley is a contributor to Qmed.
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[Image courtesy of Intuitive Surgical]