In short
Israeli company Premia Spine has developed an implant which it says offers patients with certain spinal disorders an alternative to traditional fusion surgeries. The company says it enables a quicker recovery and greatly reduces the risk of reoperation.
Background
According to a recent study of lumbar spinal fusions, one in four elderly fusion patients being treated for Lumbar Spinal Stenosis or Spondylolisthesis had to have a second operation on the spine within two years of surgery. In the study, nearly one in two elderly patients who underwent fusion surgery had to be readmitted to hospital after complications.
Premia Spine reckons it has the answer with its new device, which replaces traditional fusion surgery with a flexible joint. The device, called TOPS has a central polyurethane unit that moves, recreating motion in all directions.
After completing five-year follow-ups on patients from trials in Belgium and Israel, Premia Spine believes its results are significantly better than those achieved by fusion. The TOPS System overall reoperative rate is less than five percent, according to the company.
The TOPS System is CE marked and now available in Germany, Austria, UK and Turkey, as well as Israel. It will soon be launched in Belgium and Switzerland. By April the company expects approval to sell the product in at least one Asian country. It has submitted applications in Hong Kong, Singapore, India and Thailand and Sacher foresees approval in those markets by the end of the year.
Company comments
“With the TOPS System, instead of immobilising we replace the diseased segment with an artificial joint,” Premia Spine Chief Executive Ron Sacher said.
Regulatory status
Premia Spine is conducting clinical trials in the United States but Sacher said it could take five years to get U.S. FDA approval.
Source: Reuters
published: March 7, 2013 in: Launches / Withdrawals, Spine, Techniques