Philadelphia, Pennsylvania-based Premia Spine, Ltd. has announced the launch of its FDA pivotal study of its new TOPS System. The first surgery was performed by Steven DeLuca, M.D. of the Orthopedic Institute of Pennsylvania. The new TOPS device has been in commercial use in Europe for over five years.
“I am very pleased with the ease of the procedure and the immediate post-operative result,” stated Dr. DeLuca, in the company’s July 20, 2017 news release. Dr. DeLuca performed the surgery at Pinnacle Westshore Hospital in Harrisburg, Pennsylvania.
“We are excited about the opportunity to provide U.S. patients with access to the only posterior arthroplasty device for degenerative grade I spondylolisthesis and spinal stenosis, with thickening of the ligament or scarring of the facet capsule,” said Premia Spine CEO Ron Sacher.
The Premia Spine news release indicated, “The IDE study will take place in 30 institutions and enroll 330 subjects. Patients will be randomized to either the TOPS System or lumbar fusion (i.e., an interbody cage plus screws and rods), with a 67% likelihood of receiving the TOPS device.”
Sacher told OTW, “There wasn’t one particular challenge in setting up the new TOPS IDE study. It’s been a process that began with the redesign of the TOPS device in 2011 to make it smaller and simpler to implant.”
“That activity has paid off in Europe, where we have been in commercial use for over five years with excellent results. We worked closely with the FDA on designing the protocol. The goal posts have definitely moved since the 2006 IDE [investigational device exemption] vintage studies pursued by Impliant, Facet Solutions, Archus, and Stabilimax.”
“My sense is that the FDA would like to have spinal stenosis patients treated with non-instrumented surgery or maximum a Coflex. For the more severe patients with degenerative spondylolisthesis and spinal stenosis—where there is a need for a more thorough decompression and segmental restabilization—an instrumented fusion is warranted. And that’s where we fit in.”
“Once we nailed down the protocol, I went out to recruit sites for the study. The reception has been beyond my most optimistic expectations. Surgeons understand the need for a device that can treat this patient population without sacrificing the disc and segmental motion.”
“We have approval for 30 sites. The FDA wanted a very homogeneous patient population, with a heterogeneous surgeon investigator group. We have neuro and ortho surgeons—single practitioners and large groups—private practice and university settings. We have a few more slots available and welcome motivated surgeons with the clinical interest and infrastructure to join us.”
I have spinal stenosis with an L4 impingement as to which I have found no relief or resolve by injections. I am working with the St. Lukes Hospital system in Bethlehem, Pa. I was advised of this technique and FDA trials. I thought it may be successful for my condition.
I am looking forward to hearing from you and hope I may become a candidate for the procedure. All studies and diagnostics are with the St. Lukes Hospital at the Anderson Campus in Easton, Pa. Please contact me at any time.
Respectfully,
Paula Burkhardt
This is available in Europe with some of the top surgeons in the world. If you would like to discuss it, please contact me.
I have been told that I am a candidate for TOPS. Would appreciate it you told me of any doctors in Europe that are doing this. I know they have been doing this for at least 5 years, but they mainly do ADR
I am wondering if the TOPS surgery done in Europe has been successful and if so, where can I read about the results. I’m having difficulty finding anything on the internet. I am an Italian/USA citizen and also wondering if any of these surgeries are being done in Italy or France. I’m not there yet as a candidate for fusion, but I have asked my doctor about the possible need for it and after speaking with several people who have had spinal fusion, I am in no hurry to receive it. Thank you for any information you might share. Sincerely, Jacqueline
I have spinal stenosis in L-4 and 5. Would you please send me more information about the doctors and places where the TOPS is offered in Europe. Thank you in advance for you help. Carol Horst
I’ve been told I need spinal fusion due to severe stenosis at L3-L4 and L4-L5 which causes numbness in my right foot. I’m flexible, active and in good health and want an alternative to spinal fusion. I’ve read about TOPS and would like to explore this option either as part of the study or as a patient in a location that currently uses this device. Please send any information.
72 years old with spinal stenosis. Had lamenectomy at lumbar L2 to L5 IN 2012. I refused to have a fusion procedure which was recommended by Keck center of USC. I continue to have bilateral lower extremity weakness and claudication. The TOPS procedure from what I have read is the future treatment for spinal stenosis.
May I know which country in Europe now officially have this new Tops device ， thank you very much
I am also interested in knowing where in Europe the TOPS procedure is being done and what steps are needed to do to start the process.
Have you hit California yet? Like Standford or UC Davis? I have to take care of a fusion but don’t want it done traditionally. I need movement. I don’t want to follow up years later with more surgery! Please let me know if there are any surgeons here in California. I’m in Northern California and can also go to Oregon if any there as well. Thank you. I really need to resolve this soon.
I am interested in knowing, as soon as possible, the names of surgeons that perform the Premia Spine Tops System in the Tampa, Sarasota and St. Pete, Florida
Thank you, Louise Spellman
I am 69 years old will it be 70 soon I have l 4 an L-3 with a ruptured disc little offset pressing the spinal column itself. I am experiencing sharp pains when I bend down to pick something up and try to come back up again the only way I can get relief is if I suspend my body somehow with my hands and arms so that my feet don’t touch the ground seems to last for a while. I’m really concerned because I don’t want to end up in a wheelchair if it smashes that area of my spine I live in Dallas Texas there is a Baylor Scott White in Irving Texas just a few miles away I’m going to see my third pain management doctor this Friday but I would really like to hear from you before then. Thank you everybody stay safe!!
Hi! My name is Nadine Brunner and i have 3 children. I was diagnosed with spinalolathesis with spinalstenosis. My lifestyle has severely changed with this disease. I cannot stand nor walk for any length nor distance. I have to sit down to do anything. I habe a stool in every room of my house to wash dishes, fold clothes, cook etc. My personal life with my wonderful husband has changed drastically. Our sexlife is nowhere near what it used to be. Im in severe pain on a daily basis. Please help me. I would like to be in the study or if you can reccomend me to a hospital that does the “Tops” procedure that would be great. I really dont want fusion due to all of the horror stories ive herd. I personally know people who are extremely worse after having the fusion. I just want ro be able to go for a walk in the wooda while camping with my family. I hope you can help me. Thank you so much for reading my story. I dont want to live in all of this pain anymore. Please help.
Is there any update of the TOPS IDE study in the US?
How close are they to obtaining full approval for use in the US?
Which countries in Europe is this approved? And how far away until the U.S. approves this procedure/device? Thank-you!
Did you ever find out when this will be offered in the US or where we can go in Europe to have it done?