Premia Spine, Ltd, a medical device company headquartered in Tel Aviv, is launching the TOPS spinal implant—which had been under development for years with another Israeli firm, Impliant, Ltd. TOPS is an acronym for Total Posterior Spine System and it differs from other spinal implants in several ways but most pronounced is that it has a central polyurethane unit that moves, recreating motion in all directions.
According to Tova Cohen, writing for Reuters, the device is an alternative to fusion surgeries, and facilitates a quicker recovery for the patient as well as a reduced risk of reoperation.”With the TOPS System, instead of immobilizing we replace the diseased segment with an artificial joint, ” said Premia Spine CEO Ron Sacher. He compared the procedure to hip and knee replacements that patients now undergo.
Sacher noted that fusion surgery in the lower back eliminates one of the three key motion segments, making the other two segments work much harder. Within a few years, he said, patients often require more surgery.
According to a study of lumbar spinal fusions in the United States, presented at a symposium in Barcelona last year, one in four elderly fusion patients being treated for spondylolisthesis had to have a second operation on the spine within two years of surgery. Nearly one in two elderly patients who underwent fusion surgery had to be readmitted to the hospital suffering from complications.
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. Patients who’d been treated with the TOPS System’s experienced overall reoperation rate of less than 5%, Sacher told Reuters.
The TOPs System is not yet available in the United States but is being offered in Germany. The company expects to be profitable by the end of 2014.
When is this product comming to America? is there plans for it release to America?
would this help with scoliosis? I’m 30 years old and was told when I was 21 that I have the spine of a 70 year old. I’ve had it since birth and have never had any surgeries or taken meds for the pain. I live in pain EVERY day, but have been waiting for a breakthrough like this. I do, live in the US, but would be willing to travel is this could help me.
I am interested in this procedure as I have spinal stenosis, and expect to have surgery
can you guide me how to proceed, in Israel
thanks
Barry
I have been trying trying for the longest to have someone from Premia send me some type of informtaion so that I can Embark on the TOPS (Premia Spine) episode of my life. I am 71 young years old and have had problems with my lower back for about 15 years. Please do not disregard this 15th attempt of trying to have this surgery done. Help me get my life back. Please finally give me some professional information You seem to be the only place where I can get just what I believe I need. As I state I am 71 years of age, Not rich and my only insurances are Health First, Medicare, and some Medicaid. please send me a response Negative or Positive at least I’ll know better how to continue forward.
Nick. I am not a professional, I am a recipient of the TOPS system. Where do you live? I just had my spine surgery in Cincinnati, Ohio. I am 6 weeks post surgery and am very pleased with the outcome so far. I suggest you email the CEO directly at Premia Spine . Mr Ron Sacher at ronsacher@premiaspine.com
He has been a great help in finding a neurosurgeon that does the TOPS system. I go for my 6 week check up and X-Ray next week.
Hoping you’ll be a candidate for this amazing surgery. I too am 70 years young, and did not want to settle for a fusion.
Have a good day and search for a neurosurgeon close to you. Good luck!
Debi
Is 2018 and I’m hurting?
https://spinalnewsinternational.com/us-fda-approves-ide-study-for-premia-spines-tops-system/
“SPINAL NEWS:
US FDA approves IDE study for Premia Spine’s Tops system
9th May 2017 1013
Premia Spine has secured US Food and Drug Administration approval for its pivotal study of the new Tops system.
“We are excited about the opportunity to provide USA 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,” says Ron Sacher, chief executive officer of Premia Spine.
The new Tops device, with a 30% smaller footprint and a simpler surgical technique to the original device, has been in commercial use in Europe for over five years.
The Investigational Device Exemption study is planned to take place in 30 institutions and enroll 330 subjects. Patients will be randomised to either the Tops system or lumbar fusion (ie. an interbody cage plus screws and rods), with a 67% likelihood of receiving the Tops device.
The study’s lead investigator is Dom Coric, chief of neurosurgery, at Carolinas Medical Center, Charlotte, USA. Clinicians who have received approval or are in the process of securing Institutional Review Board (IRB) approval include Josh Ammerman and Josh Wind (Sibley Hospital, Washington, DC, USA), Neel Anand and Hyun Bae (Cedars Sinai, Los Angeles, USA), Steve DeLuca (Orthopedic Institute of Pennsylvania, Harrisburg, USA), Jason Huang (Baylor Scott & White), Armen Khachatryan (The Disc Replacement Center at Jordan Valley Medical Center, West Jordan, USA), Andy Kranenburg (Providence Medford Medical Center, Medford, USA), Scott Leary (Scripps Health, San Diego, USA), Ali Mesiwala (Southern California Center for Neuroscience and Spine, Pomona, USA), Kent New, Steve Pirris, Eric Nottmeier, and Ali Chahlavi (St Vincent’s Medical Center, Bridgeport, USA), Pierce Nunley (Spine Institute of Louisiana, Shreveport, USA), Rick Sasso (Indiana Spine Group, Carmel, USA), Bill Smith (Western Regional Brain & Spine, Las Vegas, USA), Don Whiting (Allegheny Health Network, Pittsburgh, USA), Phil Yuan (Memorial Long Beach Hospital, Long Beach, USA) and Jim Zucherman, Ken Hsu, and Dimitriy Kondrashov (St Mary’s Medical Center, West Palm Beach, USA).
According to a press release, other spine research centers are currently preparing their IRB submissions to join the study. Clinical sites will be measuring Oswestry Disability Index, Visual Analogue Scale for pain, neurologic function, device integrity, reoperation rates and other quantitative outcomes for the study device and the fusion control. “Our goal is to establish the superiority of the Tops system versus traditional lumbar spinal fusion,” explains Sacher.”
What do you have for C2-3 – My 97 y/o mother is very interested, & most active, walks a mile QD, gardens, naturally drives, cooks & is 120 lb & 5′ 3″ her college size to date.
Unfortunately she endures neck pain & on OTC Rx only.
She no longer fly’s a plane.
I am looking for Doctors in the Dallas Texas area that do the TOPS spine procedure.
thanks in advance for any assistance you may provide
sincerely John Berryman
I was referred for fusion surgery in November 2018. I will not undergo this procedure if there are other options available; none of my three neurosurgeon consults were willing/able to discuss ANY alternatives. My last consult admitted he had never heard of TOPS but assured me if it involved retaining movement, “It was definitely NOT for Paula!” That is a quote.
Dx: Multilevel degenerative disc disease and facet arthropathy ( T9 – S1) with significant/severe central canal stenosis L3 – 4 level.
I am not overweight and in general good health besides my spine.
Would you please send me information On the TOPS procedure and the timeline on when/where/if this is available and whether
I might be a suitable candidate?
I sincerely thank you in advance!
Paula Witt
Hi Paula,
Did you ever get a response to your inquiry about TOPS? I am scheduled for L4/L5 fusion March 4th and am very interested to know how the TOPS clinical study is coming along.
Thank you,
Pam
Pam F
No I never received a reply. Lots of things postponed 2020 but I am once again hard at work trying to locate ANY person/entity that has an update on this procedure.
And you? Have you had the fusion surgery?
Hi Paula. I was enrolled in this study and randomized to receive the device. I am 6 weeks and a few days post surgery. Taking no pain meds at all. Went back to work full time at 4 weeks —office type job. So far, so good but it’s all a new frontier for me.—Bionic Woman
Hello.
My husband suffers from stenosis and spondylolisthesis (L4-L5) but does not want a spinal fusion. For this past year, we’ve been waiting to hear of the TOPS spinal implant approval by the FDA. Meanwhile, my husband’s symptoms continue to worsen; every 3 months or so, he requires an injection in his back to temporarily relieve his discomfort.
We were told late last fall that it was believed TOPS would be approved in January 2023. To date, we have had no updates and are unable to find any information pertaining to the pending approval. Any information you could provide would be most appreciated.
Judy
Dear Judy,
The company has announced that it is now expecting an FDA decision in the coming couple of months.
Robin Young, editor
any news on Tops approval??
Yes. The FDA approved it for commercial sale in the United States a few months back.
I just had the TOPS system surgery, and I have no pain in my legs for the first time in 11 years. The premier US surgeon is in Santa Monica, California with an office also in West Hills. His name is Dr. Jared Ament. There is a YouTube video of him performing the first one in the US after FDA approval for commercial use.
Hi Leo,
I am scheduled for this operation but the insurance company refused to agree to it calling it “medically unecessary” and Investigational. What insurance company do you have?
I am a 52 y/o physical therapist with L4 spondylolithesis and canal stenosis L4 – S1. I would highly value feedback from those of you out there that have had the TOPS spinal system implant rather than the US traditional gold standard TLIF. I’d be interested to know how long ago you had surgery, if you had to have any additional surgeries and information regarding whether or not you are pleased with your outcome. Thank you very much!
Has TOPS been approved in US?
I was told it would be mid June of 2023.
Yes, It is!