Tel Aviv-based Premia Spine has developed an implant to treat spinal disorders without fusion, according to Reuters. The TOPS system is a polyurethane unit that is fixed to the spine and designed for motion preservation, unlike fusion which eliminates of the three motion segments. The implant can be used to treat spondylolisthesis and lumbar spinal stenosis.
So far trials have been conducted in Belgium and Israel, and have shown patients to have significantly better results than with fusion, according to the release. However, the Premia system is also more expensive and may not be covered by insurance.
The TOPS system is available in Germany, Austria, Britain, Turkey and Israel. Premia is conducting clinical trials in the U.S., and it could take five years for FDA approval.
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So far trials have been conducted in Belgium and Israel, and have shown patients to have significantly better results than with fusion, according to the release. However, the Premia system is also more expensive and may not be covered by insurance.
The TOPS system is available in Germany, Austria, Britain, Turkey and Israel. Premia is conducting clinical trials in the U.S., and it could take five years for FDA approval.
More Articles on Devices:
Ascendx Spine Recognized by Southeast Medical Device Association
Zimmer Releases DTO 5.5 Spine Fixation System for Disc Degeneration
7 New Orthopedic & Spine Device Launches & Releases