Many patients scheduled for a major spinal operation naturally worry that they
might find themselves in a wheelchair due to a surgical error, or simple bad
luck. While this happens only rarely, it is a possibility. The results of
orthopedic surgery are as good as the specialist who performs it – but today,
the risk is much reduced. Not only is there computer-assisted navigation for hip
replacement, for example (introduced in the past decade), but now there is a
robot that guides orthopedic surgeons in performing operations customized for
each patient’s anatomy. The world’s first such robotic system, called
SpineAssist, is Israeli – based on the work of a scientist at Haifa’s
Technion-Israel Institute of Technology and marketed around the world by Mazor
Robotics (www.mazorro botics.com) of Caesarea.
Ori Hadomi, the publicly
traded company’s CEO, visited Israel recently. SpineAssist is the first
surgical-guidance robot for orthopedic surgery to receive full approval from the
US Food and Drug Administration and the European CE. Hadomi has headed the
company since 2003, and moved to New York last summer for three years to promote
SpineAssist’s marketing.
In an interview with
The Jerusalem Post to
discuss the progress of the system, the master’s graduate in industrial
chemistry and business administration at the Hebrew University and the
University of California said the $750,000 system is taking off not only there
but also in Europe, Russia and Asia.
THE SYSTEM has been known longer –
three years – to Israeli orthopedic surgeons than to those abroad, as some 400
procedures have already been performed with much success at the Hadassah
University Medical Centers in Jerusalem’s Ein Kerem and on Mount Scopus and
Haifa’s Carmel Medical Center. Other Israelis will follow, said Hadomi, who
predicted that using SpineAssist for spinal and other orthopedic operations will
be regarded as the standard, while the company upgrades the system for even
better performance.
“Patients will demand robot-guided back surgery,” he
predicted.
The system was invented by Prof. Moshe Shoham and colleagues
in his robotics lab at the Technion, which patented it and has stocks in Mazor
Robotics.
SpineAssist, which allows surgeons to plan and perform any
spinal surgery safely and accurately, from the simplest to the most complex,
does not replace surgeons but helps them safely, accurately and efficiently,
reducing radiation for pre-surgical scanning and optimizing clinical outcomes,
said Hadomi. It is not just his word, but based on independent clinical studies
that persuaded the FDA to approve it.
SpineAssist is an integral part of
minimally invasive spinal surgery, as opposed to open spinal surgery, in which
the surgeon needs a direct field-of-view to spine. This means creating an
incision large enough to reach the spine and expose a full view. In
minimally-invasive surgery, the surgeon makes small incisions to allow either
keyhole visualization of the operating field or pulls back the tissues beneath
the skin to expose the spine. To compensate for this limited field of view,
surgeons use fluoroscopy (Xrays) to view their progress, said Hadomi.
But
comparative studies have shown that robotic guidance can produce results more
accurate than in open surgery – not to mention with less pain, faster recovery
and fewer repeat operations.
Prior to surgery, the patient undergoes a CT
scan of the spine. On the day of the operation, while under anesthesia, two
X-rays of the spinal column – one from the back and the other from the side –
are performed. Using special algorithms, the SpineAssist merges the images to
create a three-dimensional “blueprint.” All this is necessary to plan and carry
out the placement of metallic screws that hold the vertebrae together, whether
the discs are damaged or missing, or to repair deformities, as in
scoliosis.
A SpineAssist platform is mounted on the back to guide the
surgeon on where to optimally drill holes in the bones – within one millimeter
(a fifth of the width of a coarse human hair) in accuracy. This minimizes the
risk of harm to the spinal cord and blood vessels, as well as the patient’s and
the medical team’s exposure to radiation, which is halved, said
Hadomi.
The procedure is carried out with a $1,200 disposable robotic
implant called Emerald (after one of the jewels on the breastplate worn by the
High Priest in the Temple, Hadomi explained). But it is the surgeon who actually
makes the holes and inserts the implant, not the robot, and it is he who can
make smaller incisions in the skin and muscle below because he needs less
leeway, added the CEO. Once a hospital purchases the system, the cost of the
Emerald – which cannot be reused – is covered by the health basket.
PROF.
MEIR Liebergall, chairman of the orthopedic surgery complex at Hadassah
University Medical Center, praised the work of Mazor Robotics. “We have
cooperated with them for almost a decade, especially in implementation of the
system,” he said. “This has been in accordance with our Hadassah philosophy of
boosting minimally invasive and computer-aided surgery.”
Liebergall, who
is a world expert in using computers to guide the implantation of screws for hip
replacement, does not perform the spinal surgery.
This procedure is
carried out at Hadassah by Dr. Leon Kaplan and Dr. Yair Barzilai. Liebergall
said there are only four or five surgeons in the whole country who use the
SpineAssist system so, far after undergoing training abroad. They learn through
computerized simulations and by working on cadavers.
“The Mazor Robotics
system is now used at the two Hadassah hospitals “on a daily basis. It doesn’t
solve all orthopedic surgery problems, but it is very helpful,” he
said.
Except for a few cases, Kaplan and Barzilai have not yet used the
system on children suffering from scoliosis, in which the spinal column curves
away from the middle or sideways. Scoliosis can be congenital due to improper
formation of the vertebrae or fused ribs during gestation or early in life; be
caused by poor muscle control or paralysis due to diseases such as cerebral
palsy, muscular dystrophy, spina bifida and polio; or be of unknown cause.
Whatever the type, scoliosis can cause functional and esthetic problems. But
Liebergall expects that it will routinely offer such surgery at Hadassah within
the next two years.
Other potential applications for the system, whose
price will apparently rise, are very exciting, he added. “It won’t take long
before it could be used for lengthening bones and for treating vertebrae damaged
in trauma cases. With some modification, it could be used for hip replacement
surgery as well. And the fact that it is Israeli technology leading the world is
wonderful.”
Hadomi notes that the company has a total of 50 employees in
Israel and Europe, but is certain to expand as demand for the robotic system
grows.
“It might even be used eventually in brain surgery.”
The
company has offices in Atlanta, Dallas, Houston and Chicago in addition to New
York. “We have signed agreements in Italy, Russia and Holland, and are expanding
to Belgium, France, Spain, Portugal and the Far East. The potential is huge.”
Some components are manufactured by the Tamuz company at Kibbutz Jezreel, and
others by subcontractors in Switzerland.
“This is the smallest medical
robot in the world, and has been used for over 2,000 operations and 10,000
implants so far. There is no other that works on the spine. We do not expect
serious competition, and our product is patented. Our sales will reach hundreds
of millions of dollars, but we will not relax. We will work on new generations
of robotic surgical equipment,” concluded Hadomi.
And, it is hoped,
patients’ having to spend the rest of their lives in a wheelchair due to a
failed operation won’t be even a passing fear.