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.

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