- Title: ISRAEL: New implant brings high hopes for back pain relief
- Date: 19th April 2013
- Summary: RAMAT POLEG, NETANYA, ISRAEL (APRIL 10, 2013) (REUTERS) VARIOUS OF SPINE MODEL SHOWING TRADITIONAL FUSION METHOD (SOUNDBITE) (English) RON SACHER, CEO OF PREMIA SPINE, SAYING: "We believe that because of the lower re-operative rates and the better outcomes, in the long term this is a much better solution for the healthcare system than traditional fusion and we hope that
- Embargoed: 4th May 2013 13:00
- Keywords:
- Location: Israel
- Country: Israel
- Topics: Health,Science / Technology
- Reuters ID: LVA2Q7VQTTCZNLD12MFFR9EBTU5R
- Story Text: Four years ago Israeli moshav farmer Yehuda Schwartz was often bed-ridden and feared he would never be able to plant the olive groves he'd dreamed of during his former career as a writer. Suffering from spinal stenosis (LSS), a form of spinal arthritis associated with ageing, Schwartz thought his final years would be lived out immobile and in severe pain.
But having been one of the first people world-wide to receive a new medical implant developed by Israeli company Premia Spine, the 79-year-old says his life has been rejuvenated.
Schwartz says that back in 2009, he was in constant pain.
"On a scale of one to ten I was close to nine. I was close to nine. Not only is there pain, which is constant, but your whole psyche is affected. It's not just your body....I couldn't concentrate on my work," said Schwartz.
Schwartz says the TOPS implant changed his life almost immediately. He says he was cured of all back pain within a week of the operation.
"(It was) not even a week. Less than a week I was back to work. I don't think it was a week. The operation was on a Thursday, Sunday I said I'd walk up the stairs, Monday I was released. By the end of the week I was completely normal," he said.
Since then Schwartz has cleared his overgrown land, planted an orchard full of olives, can bend over with no ill effects, and is even able to run at a pace that would put people two decades younger to shame.
Premia Spine says its TOPS implant is a superior treatment to traditional fusion surgeries, enabling a quicker recovery and greatly reducing the risk of reoperation. The device is fixed to the spine with screws, and differs from other products on the market in that it has a central polyurethane unit that moves, allowing motion in all directions. It addresses two lower back ailments: spondylolisthesis, commonly known as a slipped disc, and lumbar spinal stenosis (LSS).
"What we've seen, much like with hip replacements and knee replacements is that you're able to replace those joints in the lower back with an artificial joint and when you can do that the patient can get right back to normal activity that they may not have engaged in for years because of the pain they've been suffering from," said Ron Sacher, Premia Spine's chief executive officer.
TOPS allows the surgeon to remove diseased parts of the spine and then stabilise it with an artificial joint that restores the function of a normal posterior spinal column. Sacher says the titanium-sandwiched implant not only gives patients normal, pain-free mobility, but it also protects adjacent levels of the spine from similar degeneration - a common unwanted side effect of conventional fusion surgery.
"The surgeon has decompressed the spine during surgery in order to remove the bony elements that are pressing on the nerves, so now with the TOPS system we're recreating the normal function of the spine with an artificial joint, much like a knee replacement or a hip replacement. We've been able to recreate the normal function of the lumber spine in this particular device, and you can see the device basically moves, so instead of fusing the two vertebral bodies or rigidly fixing them we're recreating the normal function of the lower spine with this particular device."
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 patients often require more surgery. According to a study of lumbar spinal fusions in the United States, whose results were presented at a symposium in Barcelona last year, one in four elderly fusion patients being treated for LSS or 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 hospital after 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. The TOPS System overall reoperative rate is less than five percent, Sacher told Reuters.
The drawback to Premia Spine's device is that it is more expensive, and while the extra cost is covered by public health systems, private insurers do not always do so. But Sacher believes his system's lower re-operative rates make it a better longer term solution for patients and that it will become the surgery of choice world-wide.
"We hope that in spines we will see the same change that's taken place, namely a move from fusion to hip replacement and knee replacement also taking place in the lumber arena as well," he said.
According to Sacher, 650,000 people a year undergo lumbar spinal fusion for a variety of ailments. Premia Spine began selling its product late last year. It's currently available in Germany, Austria, Britain, Turkey, and Israel and will soon be launched in Belgium and Switzerland. The company has submitted applications in Hong Kong, Singapore, India and Thailand and Sacher foresees approval in those markets by the end of the year.
Premia Spine is conducting clinical trials in the United States but Sacher said it could take five years to get U.S. Food and Drug Administration approval. - Copyright Holder: REUTERS
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