Medical Device Daily

NEW YORK The slow progress in the adoption of new technologies in orthopedic repair and reconstruction, described by one panel at this year's Piper Jaffray Health Care Conference (see accompanying story), was further highlighted by a second panel specifically focusing on the artificial disc, the very newest product in this arena.

Introducing the panel, titled “Acceptance of New Spine Technologies from the Perspective of Third-Party Payers,“ was Piper Jaffray (Minneapolis) senior med-tech analyst Thom Gunderson, who asked the panel if the uptake of this very groundbreaking technology is “a zero-sum game, going to the moon, or a 2% ramp-up?“

The answer would seem to be the last of these, according to the panel, with Thomas Errico, MD, of the Orthopaedic Institute at New York University Medical Center's Hospital for Joint Diseases (New York), an inventor and orthopedic surgeon, summing up a very key problem: “How to pay for these devices“ while dividing up “the healthcare pie in general.“

That's not particularly good news for the Charité, the artificial replacement disc from Johnson & Johnson (New Brunswick, New Jersey), which last year won the first commercial approval in the U.S. (Medical Device Daily, Oct. 28, 2004).

Tom Sherman, MD, a spine surgeon who practices in Minneapolis-St. Paul, noted that use of an artificial disc is “an interesting concept for allowing motion preservation [of the spine] safely and effectively.“

But while Sherman said that he had been trained in the use of the Charitédisc and had “some [patients] in the pipeline,“ he had performed no implantations of the disc as yet.

Asked why not, Sherman expressed concerns about “potential big hurdles and challenges“ on the clinical side. These concerns included questions about the company's clinical trials — a comparison with spine cage devices rather than with spinal fusion, he said — and the risks of mortality, this latter the result of an anterior surgical approach that requires a tricky negotiation around the aorta and vena cava.

Sherman said he had additional reservations concerning the training for use of the device, saying it was done on “cat spines rather than cadavers“ and that the procedure requires a high level of technical demands.

“You need more technical skill. You have to completely mobilize that disc space and get [the disc] in the right position. If you're off by 3 mm, the results are not as good.“

He also said that, to his knowledge, reimbursement had been “uniformly denied so far.“

Errico, the panelist most supportive of the artificial disc technology, reported his facility doing many implantations of the Charitésuccessfully, calling it “ideal,“ and that the procedure, done minimally invasively, allowed the patient to stand “the next day.“

He added: “There's no recuperation, you sort of get your instant gratification and maintain the motion of that segment“ — as dramatically compared to the long recuperation periods of spine surgery. And he predicted that the disc replacement procedure would reach 20% of available spine surgery cases “in the next 10 years.“

Both Errico and Sherman said that a key issue was patient selection in treating spinal problems.

Patients may come with a variety of complaints about “other stuff that goes along“ with back pain, Errico said, and that the surgeon must “sort out the wheat from the chaff. Patient selection is overwhelmingly the biggest challenge for spine surgeons in applying any of these technologies. It definitely requires more than looking at an MRI scan and deciding.“

The artificial disc offers “no panacea,“ he said.

Still another barrier cited by Sherman was resistance to the technology by neurosurgeons who, he said, “do half the spine surgeries. They're very, very slow in accepting and adopting the artificial lumbar disc and jumping on that bandwagon.“

Better chances were given by the panel to the proposed uses of artificial discs in the cervical region and artificial nucleus replacement technologies.

Sherman noted that such artificial discs in the cervical area would be much easier to implant.

“The approach [for cervical disc implantation] is identical to decompression of nerves and cervical fusion . . . Some of those hurdles resistant to acceptance [of an artificial disc] in the low back just don't exist in the neck,“ he said.

And Sherman supported the use of nucleus replacement as requiring a simpler, traditional procedure for the surgeon. “Also, it doesn't burn bridges. In those patients in whom it does not work, it's very easily revisable — much more easily than an artificial disc.“

Addressing the issue of reimbursement once again, panelist Terry Corbin, MD, said the advantage of the artificial disc for payers is getting “back to work faster, so why wouldn't you want to pay?“

But he added that the process of regulatory approval hadn't answered “all the questions that physicians and insurance companies need to have answered.“

Corbin cited the principle of evidence-based medicine to prove “that your new therapy has to provide good value compared to the next best alternative. It's not real clear what the next best alternative is.“

He added that comparing the Charitéto fusion cage devices had not equaled a comparison to current state of the art and so “that doesn't exactly answer the question.“

Given the various hurdles to be crossed, Errico said, “traditional fusion surgery is not in danger, but [the artificial disc] is going to make steady inroads,“ and eventually “cannibalize“ other sectors of the spine repair market.

Besides projecting artificial discs eventually penetrating 10% to 15% of the traditional fusion market, he offered the view that “spine surgery will continue to grow.“