The primary U.S. surgical procedure with FDA-approved TOPS™ System, led by Jared D. Ament, MD, a board-certified and fellowship-trained neurosurgeon.
NORWALK, CONNECTICUT (PRWEB) JUNE 30, 2023 – Premia Backbone, a medical expertise firm revolutionizing the remedy of continual leg and again ache, immediately introduced that the primary surgical process utilizing the TOPS™ System, a state-of-the-art movement preservation spinal gadget, has been efficiently carried out within the U.S., instantly following its approval by the Food and Drug Administration (FDA).
“Spinal stenosis and spondylolisthesis sufferers now have entry to a lumbar movement gadget that’s superior to fusion, in keeping with its FDA label,” stated Ron Sacher, CEO of Premia Backbone. “We’re thrilled to deliver the TOPS™ System to sufferers who search a non-fusion resolution for his or her leg and again ache. We’re very grateful to all of the surgeons who made it potential to deliver our aspect alternative product to the US market, and we’re significantly lucky to have Dr. Jared Ament carry out the primary business TOPS process.”
The TOPS™ System is an revolutionary resolution designed to deal with spinal stenosis and spondylolisthesis. This FDA approval follows in depth medical trials that demonstrated the system’s security and effectiveness in assuaging again ache and bettering bodily operate.
“This milestone is greater than only a testomony to our expertise—it’s a testomony to the laborious work and dedication of our total crew,” added Peter Wehrly, President of Premia Backbone. “We’re excited to see what the longer term holds as we proceed to drive developments in spine care.”
The groundbreaking process was carried out by Dr. Ament, a famend board-certified fellowship-trained neurosurgeon on the Neurosurgery and Backbone Group on the West Hills Hospital & Medical Heart situated in West Hills, California. This primary-of-its-kind operation marks a major milestone within the remedy of complicated spine issues, delivering hope to tens of millions of sufferers affected by debilitating leg and again ache. Premia Backbone extends honest appreciation to West Hills Hospital & Medical Heart for his or her instrumental position in making this groundbreaking process potential. Their foresight and dedication to embracing cutting-edge medical expertise, such because the TOPS™ System, underlines their dedication to advancing affected person care. Because the pioneering establishment within the U.S. to supply the TOPS gadget, their endeavors considerably contribute to the ahead momentum of spinal care nationwide. Premia Backbone’s partnership with Dr. Ament and West Hills Hospital & Medical Heart underscores the shared dedication to progress and patient-centered care.
“The TOPS™ expertise for me is revolutionary as a result of, till now, we’ve by no means had an possibility for posterior decompressive surgical procedure that permits us to stabilize and never fuse. It didn’t exist. For a affected person with a minor slip and vital posterior stenosis with stress on the neural parts, we will now carry out an intensive posterior decompression and open the nerve canal,” says Dr. Ament. “Till immediately, once you did one thing that in depth, you needed to carry out a fusion. You’d put fusion rods and screws from behind and infrequently put a cage within the disc house in entrance. The TOPS™ expertise permits us to carry out a really aggressive decompression to launch the nerves, which is our major aim for our affected person and their signs and protect movement. In doing so, we basically exchange the sides and the lamina, with out touching the disc house, and permit mobility to be maintained. I consider TOPS will add to a affected person’s high quality of life—now and sooner or later.
When queried on his emotions about being the pioneer U.S. doctor to execute the process following FDA’s approval, Dr. Ament expressed the next sentiment. “I’m excited. I’ve executed many of those underneath the auspices of the FDA trial, so I’m snug with the process. My follow is attempting to be on the leading edge. To not rejoice it, however to supply our sufferers a greater resolution. Being the primary surgeons to make use of TOPS commercially is a testomony to my companion, our follow, and the hospital for wanting to advertise the perfect expertise accessible to sufferers as quickly because it’s accessible.”
The TOPS™ System, the primary and solely lumbar spine aspect joint alternative gadget, supplies a beacon of hope for the over 100 million people globally grappling with the debilitating results of lumbar spinal stenosis and degenerative spondylolisthesis. As the one expertise of its variety designed to protect mobility post-decompression, TOPS™ presents a revolutionary different to the 350,000 sufferers yearly who historically bear lumbar spinal fusion. With a possible world market worth of $2 billion yearly, this innovation marks a transformative step ahead in world spine well being administration.
About Premia Backbone
Premia Backbone, a medical expertise firm, is dedicated to enhancing the standard of life for sufferers affected by continual leg and again ache. Its merchandise are particularly designed to supply sturdiness, stability, and elevated mobility to these combating lumbar spinal stenosis, degenerative spondylolisthesis, and associated spinal situations. The TOPS System, Premia Backbone’s flagship product, has obtained the CE mark and has now obtained approval for distribution inside america.