FDA approval for miniature robot for spinal procedures

A miniature robot for fail-proof spinal procedures has received FDA approval. Named SpineAssist, the robot is the brainchild of Technion-Israel Institute of Technology Mechanical Engineering Professor Moshe Shoham. It will be manufactured and marketed by Mazor Surgical Technologies, the company founded by Shoham in 2001.

The robot offers surgeons improved accuracy during complicated back surgery while minimizing risks associated with spinal surgical procedures. Such risks include nerve damage, which according to industry statistics, happens in 2 to 3 percent of spine injuries. No bigger than a soda can, it is attached directly to the patient’s body, pointing surgeons to the exact positioning needed for tools and implants. This is critical, says Professor Shoham, since a mistake in placement of even a few millimeters can cause irreversible nerve damage or paralysis.

"SpineAssist minimizes the risk of working free hand in sensitive regions of the spine," explains Prof. Shoham. "It conceives a plan for locating the spinal implants, but neither replaces the surgeon nor performs any operations. After examining and approving the recommendation, the surgeon inserts surgical instruments through the arm of the robot, thereby minimizing the danger of damaging vital organs."

Shoham adds that because of its high level of accuracy, SpineAssist reduces surgery time and invasiveness, expedites recovery and minimizes associated risks – such as infection and blood loss – of traditional spine surgery.

Mazor has already installed the first systems at the Cleveland Clinic Foundation in Cleveland, Ohio and Sheba Medical Center in Tel Hashomer, Israel. The company expects to install more of them at other spine centers in Europe and in the United States later this year.

The robot is being tested on a limited basis by a team led by Prof. E. Benzel and Dr. I. Lieberman at the Cleveland Clinic Foundation. Clinical trials are underway at Israeli spine centers located at Sheba Medical Center, Rabin Medical Center and Carmel Hospital. The locations in Israel will be the first to perform full-scale surgeries utilizing the device.

More than 500,000 spine surgeries are performed annually in the United States alone – a number currently growing by 8 percent a year. This creates a large potential market for the SpineAssist. According to analysts’ reports, the spinal industry is expected to triple its growth over the next eight years, reaching annual sales of $7 billion.

Mazor representatives predict that SpineAssist will become widely used. "The combination of precision, simplicity and performance reliability will play a key role in the success of the product and company," says Ori Hadomi, the company’s CEO. Mazor will begin marketing SpineAssist in the final quarter of 2004, at an estimated cost of $100,000 per unit.

According to Hadomi, the SpineAssist technology can also be applied to brain and knee surgeries, but adds that Mazor is focusing specifically on the spinal area for now. In another project, Professor Shoham is working on a surgical robot so small that it can actually fit inside a patient’s spinal cord.

The Technion-Israel Institute of Technology is Israel's leading science and technology university. It commands a worldwide reputation for its pioneering work in computer science, biotechnology, water-resource management, materials engineering, aerospace and medicine. The majority of the founders and managers of Israel's high-tech companies are alumni. Based in New York City, the American Technion Society is the leading American organization supporting higher education in Israel, with more than 20,000 supporters and 17 offices around the country.