Many people will suffer from severe back pain at some point in their lives – about 80% of the U.S. population, estimates spine care firm CERT Health Sciences (Baltimore) – yet the options for effective treatment are few.

Offering long-term relief without the use of narcotics, physical therapy or invasive surgery, CERT Health Sciences has developed the SpineMED decompression table, which it said is the next generation of spinal decompression technology that is able to isolate and rehydrate debilitated spinal discs.

“What spinal decompression really does is create the environment that allows the body to heal naturally,“ Tim Emsky, co-founder and managing director of CERT Health Sciences, told Medical Device Daily. “It's so simple, but the results are unbelievable.“

The spine is made up of 24 vertebrae separated by fluid-filled discs that cushion and protect the spinal cord. When a disc is compressed, the flow of nutrients and fluid are depleted, which can cause the disc to prematurely degenerate. “Imagine if you put a jelly doughnut between your palms,“ Emsky said. “If you squeeze it, there's going to be a point where the pressure exerted on it is going to cause the outer wall to tear. And that's exactly what happens to the discs in our back.“

With the non-surgical SpineMED treatment, “not only can we repair disc herniations through a very simple painless procedure with no side effects, but what we've also found is that we can restore the fluid content in the discs,“ he said.

The company first developed the SpineMED table in 2001, based on a decade of experience as a clinic operator treating patients with back pain. An enhanced version of the device, the SpineMED S200B/C, was developed last year and the company is now heralding its official debut.

Though spinal decompression – removing the pressure on the spine through distraction or positioning – as a treatment option is not new, Emsky said it is limited by side effects and uncomfortable restraint systems. Unlike other decompression tables, SpineMED does not use antiquated traction components such as pulleys, drums, ropes and pelvic harnesses.

“We found that the harnesses were probably the key limiting factor in the whole technology,“ Emsky explained.

In contrast, the SpineMED table captures and distracts the skeletal structure through a proprietary design that the company said is not found on any other decompression device.

Among its key features is what the company called a “first-of-its-kind“ pelvic restraint system. It said the patent-pending system improves patient comfort, patient suitability and clinical efficiency. Unlike traditional harnesses that are cumbersome and uncomfortable, the SpineMED pelvic restraint system captures any patient physique comfortably and accurately, eliminating treatment interruptions by harness malfunctions.

“With SpineMED, by simply capturing the pelvis directly with the drive mechanism, it increases the efficiency of the device such that for the same patient, same pathology, SpineMED requires half the force of our competitors,“ Emsky said. “What we found clinically is that patient suitability and tolerance to the treatment is dramatically improved.“

Because the patient is accurately positioned by the SpineMED pelvic tilt system, specific spinal segments can be targeted for the precise treatment of identified pathology. This feature eliminates the unnecessary treatment of additional segments, and any resulting side effects.

“This section electronically tilts between zero and 25 degrees, so that we can target precisely which level the patient has the pathology at. It is that focused and that targeted, so it can be very precise,“ Emsky said.

In addition, the system allows for treatment tensions that typically are 50% lower than what is required by older, harness-style units, further improving clinical results.

“Those advancements just in the pelvic restraints and pelvic tilt have changed the clinical efficacy dramatically,“ Emsky said.

The company also added an infrared element in the lumbar section of the table. That light energy “not only produces a very mild heat to allow for a better stretch of the paraspinals, but by introducing light energy at the cellular level also promotes healing,“ Emsky said.

Also unique to SpineMED is its feedback-loop system that monitors the instantaneous table tension being applied to the patient's spine every 2.5 milliseconds. Any necessary adjustments are made every 20 milliseconds, which the company said is 30 milliseconds faster than the human brain can react, ensuring the maximum effect of the treatment.

The latest SpineMED S200B/C models are built on an entirely new software and database platform offering unlimited expandability for future development. Other enhancements include expanded reporting capabilities with integrated user customizable reports; a new server with the ability to send patient data to up to 35 SpineMED tables in a clinic over a secure wireless network; an LCD video monitor integrated into the table allowing patient viewing of treatment progress, DVDs or cable TV entertainment; an upper restraint system that further improves force application efficiency by 12%; and computer enhancements that allow upgrade of software and uploading of firmware to the table microprocessor via modem.

The SpineMED was designed with portability and space limitations in mind. The wheeled unit consists of two parts – the control console and the table – which are connected with a 15-foot cord. Emsky said the modular component design allows “plug and play“ replacement and future enhancements to the technology for long-term use. “In every possible instance, we've designed the device with modular off-the-shelf hospital grade components,“ he said, “so our customers are not beholden to us for parts.“

Emsky described a typical treatment with the device. On the first visit, the patient is assessed for suitability and to rule out contraindications. Spinal disc decompression can be an effective treatment for herniated discs, degenerative discs, sciatica, facet syndrome, spinal stenosis and pre- or post-surgical patients, the company said. The operator enters the patient data into the computerized chart and sets the patient up on the table.

“They then press a button and walk away, come back in half an hour and schedule [the patient's] next session,“ he said. The devices “are that automated and that simple.“

Most patients will require a course of between 20 and 25 sessions to achieve significant remission. “Clinically we have found at least an 86% success rate,“ Emsky said, emphasizing that “these are with patients who have tried everything else and nothing works.“

The treatment – which is covered by most insurance plans – is “pretty much indiscernible to the patient,“ he explained, noting that patients can watch TV or a DVD on the overhead LCD screen or relax to music on wireless headphones. Some even fall asleep. “Relaxation is part of the key,“ Emsky said. “If you can promote relaxation and sleep, you are getting the ultimate treatment.“

And because SpineMED is easy to operate and offers quick and simple patient set-up, “What it means for some of the smaller clinics, this integrates into their practice without any impact on their current staff levels,“ he said.

The company is marketing the SpineMED S200B/C mainly to primary care physicians, doctors of chiropractic and osteopathic physicians. Emsky noted that orthopedic surgeons are also expressing an interest in the device, “especially the more open-minded ones who see that surgery may not be the option for all their patients. Where this treatment is an ideal situation in their practice is [as] a conservative modality that will vet all of their patients for surgery.“

For international sales, he noted that the device can run on any type of power and is built to hospital-grade certifications around the world.

The SpineMED S200B/C sells for $119,000, and a lumbar-only unit can be purchased for $95,000. Shipping, installation, training, and a two-year parts and labor warranty are included. The devices also can be leased for about $2,450 or around $1,945 for the lumbar-only unit, Emsky said.

“The ROI on these devices is incredible,“ he said, noting that SpineMED's capacity “is considerably higher than the pelvic harness-type machines because of [less] set-up time,“ which allows a clinician to treat more patients per day. “And one patient a month will more than cover your lease cost,“ he said. “The revenue generation is incredible.“

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