Medical Device Daily Associate Managing Editor

SAN FRANCISCO — What's happening in the spine sector is nothing short of a revolution, Scott Blumenthal, MD, said during a Wednesday luncheon at the annual JP Morgan Healthcare Conference at the Westin St. Francis Hotel.

An orthopedic surgeon specializing in the spine, Blumenthal also is president of the Texas Back Institute (TBI; Plano, Texas) as well as the director for Center for Spinal Arthroplasty at TBI.

Despite his protestations to the contrary, Blumenthal is uniquely qualified to speak on the topic, having been involved in such prominent clinical trials as that for Johnson & Johnson's (New Brunswick, New Jersey) recently FDA-approved Charité artificial disc (Medical Device Daily, June 4, 2004), in which he was the principal investigator.

Blumenthal said that the last decade has seen the rapid emergence of potentially useful new products and procedures. And minimally invasive surgery (MIS) has entered the field in a particularly big way over the past 10 years, he said.

The decade also saw the first trials for the artificial discs and total disc replacement. And he pointed to biologics as really showing advancement over the same period, culminating in the development of bone morphogenic protein.

A lot of companies, both small and large, are delving into the MIS game, Blumenthal said.

Farther out in the future — or what he termed “the view from 10,000 feet“ — he said the spine space “looks like it's going to be in miniaturization, genetics, image-guidance and robotics seems to be something we're working toward.“ Added to that, he listed the areas of biologics, including cell regeneration, disc regeneration and a range of other biomaterials.

Getting back down to the “ground level,“ he said the spine market is still a “large, fast-growing, exciting med-tech sector.“

While characterizing the sector's potential as virtually “limitless,“ Blumenthal noted that there are projections that the market could be worth more than $10 billion by 2014 at the latest.

“There are multiple aggressive spine companies, there are new entrants to the field, it's the highest-growth segment of orthopedics,“ he said. “There are significant product opportunities and a very favorable market for the technology.“

While the potential for the market is there, Blumenthal put the spine segment as still somewhat lagging behind other areas of orthopedics.

“We still conduct pretty invasive surgery, we still do fusions and it's a very complicated market,“ he said, adding that there are roughly 78 dysfunctions of the spine, with many of these very difficult to diagnose.

He said the dynamics are such that MIS has a huge growth opportunity, with the other “biggies“ being arthroplasty and biologics.

Another advantage to spine — ranked by Blumenthal as the highest-growth sector in the orthopedics space — is that this market growth enables non-fusion technology without really cannibalizing spinal fusion, the current “gold standard“ of spine treatment.

However, as these non-fusion technologies evolve, he said the total fusion numbers will go down.

Total disc replacement — meaning use of an artificial disc — is just one form of spinal arthroplasty, and potentially the most lucrative. But other technologies, Blumenthal said, also fit the definition of arthroplasty, which is essentially motion preservation technology of the spine. Other technologies within that arena include nucleus replacement — or partial disc replacement — and posterior dynamic stabilization.

While he said all of these are certainly important, he characterized total disc replacement as promising to be the most significant, likening it to the frequency of total hip and knee replacements.

While everyone may not agree on what version of this new technology is the best, “everyone agrees that total disc replacement is revolutionary. Why? — because it's the first time that we're able to relieve pain and preserve the motion,“ he said, and something not achievable with good old-fashioned fusion.

Moving on to nucleus replacement, Blumenthal said that this technology has the potential to be a spectrum treatment “expander“ and could possibly be an adjunctive therapy to the most common lumbar spine operation, the laminectomy.

One of the primary challenges to adoption of the new artificial disc replacement technology, he said, is the “incredibly slow“ adoption for reimbursement by third-party payers. “That has been our biggest challenge post-FDA approval.“ Blumenthal said that this list includes all the big health insurance companies.

He also noted that the technology has been covered under a lesser DRG reimbursement code than is necessary to cover the cost of the procedure, being lumped together with a decompression or lumbar laminectomy instead of the higher-paying spine fusion code, for which it is actually a substitution, a possible hindrance to physician adoption.

Blumenthal said he believes that the device will see off-label use to treat multi-level disc replacements. “Off label use . . . is pretty much standard-of-care in appropriately selected patients,“ he noted.

That being said, he tells physicians that he trains in the technique to stick to the standard protocols, including single-level fusions only at least through the first 50 cases. “After that, you've achieved pretty much the apex of the secondary learning curve.“

Blumenthal noted that being able to perform these multi-level procedures is not going to help just a few patients. Rather, “you're going to be able to help a lot of patients.“

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