TOPS™ System Invention Story

In 2003, in the corner of a spine meeting reserved for posters that didn’t warrant a podium presentation, there was a report on 100 consecutive patients at the Hospital for Special Surgery in New York City who underwent spine surgery. It was titled, “The Prevalence of Contraindications to Total Disc Replacement in a Cohort of Lumbar Surgical Patients.” The gist of the poster was clear. The spine department at HSS was not recruiting patients fast enough for the FDA trial on a lumbar artificial disc replacement (ProDisc) and the team wanted to understand why. 

The findings were eye-opening.

Only 5% of spine surgery patients were indicated for a lumbar disc replacement. Many were best served with a decompression (39%) without any implant. The remaining 56% underwent fusion. These patients suffered from posterior spine issues, such as spinal stenosis, spondylolisthesis, and facet arthrosis, or spinal deformity, osteoporosis, and other spine diseases.

This trigged Uri Arnin, a serial medical device inventor, to look more carefully at the fusion group. He discovered that many of these patients receiving rigid fixation of the spine had functional discs. Their problem was in the posterior column of the spine. He realized that if he could come up with a joint replacement for the facets, he could preserve the disc. His idea was to avoid fusion yet allow surgeons to remove the overgrown bony elements pressing on nerve roots – much like in hips and knees. Uri sketched some concepts on a napkin for an artificial facet joint solution to restore spinal stability after a decompression and provide patients with normal segmental motion.

He took his concepts to the North American Spine Society Meeting in October 2003. His team sat behind a one-way mirror and listened to surgeon-after-surgeon as they discussed their practices and their desires to avoid fusing their patients. The outcome of the sessions was the TOPS™ System.

This started a race to complete product development. The company had meager resources, and the investors were eager to see results. The development team, which had been working on hip and knee replacement projects, were redirected to this crash course. Within 5 quarters, the company completed design, manufacturing, testing, and approvals to begin clinical testing. The first TOPS System patient was operated on in Sao Paolo on January 5, 2005. From there, the device travelled the world, recruiting patients in Brazil, Turkey, South Africa, Israel, Belgium and eventually in the United States.

The implant changed owners, underwent design changes, and survived Covid. In June 2023, following a 37-center randomized clinical trial on over 300 patients, the FDA approved the TOPS System with a “superior to fusion” claim. This is the first and only time the FDA has granted such an elevated status to an implant in the lumbar spine.

Today, TOPS is commercial in the US and other countries around the world. Perseverance has paid off for the Premia Spine team and the thousands of patients who benefit from the TOPS System.