Premia Spine Launches FDA-Approved TOPS™ System at North American Spine Society
First Facet Replacement to Transform Spinal Treatment of Spinal Stenosis and Spondylolisthesis with Superior Alternative to Traditional Fusion Surgery
NORWALK, Conn. , Oct. 11, 2023 /PRNewswire-PRWeb/ — Premia Spine, an innovator in spine medical devices, announced the commercial launch of the TOPS™ System. The novel facet replacement system will be showcased at the North American Spine Society Meeting in Los Angeles on October 18th. Premia is partnering with leading corporate and independent distributors across the United States to provide surgeons and patients with access to the most cutting-edge posterior lumbar motion preservation technology on the market today.
The U.S. Food and Drug Administration (FDA) designated the TOPS™ System as a Breakthrough Technology in 2020 and granted PMA approval to the TOPS System in June 2023 with a “superior-to-fusion” claim, underscoring its safety and efficacy. The TOPS™ System provides patients with spinal stenosis and spondylolisthesis unparalleled advantages over lumbar fusion, including enhanced mobility, decreased post-operative neuro deficit, and more rapid and sustained return to normal activity.
“We are aligning ourselves with leading distributors that share our dedication to patient care, innovation, and the pursuit of excellence,” commented Peter Wehrly, Premia Spine’s President. “Our network’s expansive reach and sterling reputation in the spine industry will accelerate surgeon access to the TOPS System, thereby affording more patients the benefits of this groundbreaking technology.”
Ron Sacher, CEO of Premia Spine remarked, “We are excited to launch TOPS™ at NASS where we will have a series of events on Wednesday, October 18th. Board Certified, fellowship-trained neurosurgeon, Jared Ament, MD, will have a podium presentation on the TOPS™ clinical outcomes. Further, we will host a Surgical Stadium Lab Cadaver Demonstration with fellowship trained spine surgeon, Roland Kent, MD, followed by a more intimate cadaver training session for interested surgeons and distributors. Premia Spine’s launch of TOPS™ System furthers our mission to alleviate pain, restore health, and extend life for patients around the world.”
Visit NASS Booth 2707 or go to PremiaSpine.us for more information.
Media Contact
Peter Wehrly
Premia Spine
1 (303) 324-4983
PeterW@premiaspine.com
http://PremiaSpine.us
SOURCE Premia Spine