Originally Published MDDI December 2003
Nonfusion disk arthroplasty has the potential to revolutionize the spinal surgery market, attendees to an industry summit learned in October.
A number of such technologies will hit the U.S. market starting in about 18 months, and they could provide patients with an alternative to spinal fusion, presenters at HealthPoint LLC's spine industry summit said.
“These technologies are being shown to relieve the pain without fusing the spine, allowing patients to maintain normal motion,” said Robin Young, managing director of research for HealthPoint, a research and private equity firm devoted exclusively to orthopedics. “Clinical trial results for this approach show it relieves pain better than fusion. And since [the surgery] can restore the back's normal motion, it looks like a home run. The data have gotten everyone excited. It could be a game-changing technology.”
The market for such products could be vast, Young said, since more than 500,000 spinal surgeries are performed each year, and 300,000 of them are spinal fusions. He noted that industry has spent about $1 billion in the past year on research, development, and acquisitions in this area. None of the technologies are yet available in the United States, but some are in Europe, where sales have quadrupled in 2003 over 2002.
Questions remain over which manufacturers will be able to capture the market. There could be as many as 10 players, and four considered among the closest to a U.S. debut presented data at the HealthPoint summit. The four products described were the SB Charite Artificial Disc from DePuy Spine Inc. (Raynham, MA), a Johnson & Johnson company; the ProDisc from Synthes-Stratec (Oberdorf, Switzerland); the PDN-SOLO Prosthetic Disc Nucleus from Raymedica Inc. (Minneapolis); and the Dynesys from Zimmer Holdings Inc. (Warsaw, IN).
“All of these lend themselves to a minimally invasive approach,” Young said. “Most of them are disk products that fit between the disk and the vertebra. Raymedica's looks like a tiny pillow. But all are like joints for the spine.”
But, he said, what attendees wanted to know most was which product would be the first to achieve U.S. market entry and which would offer patients the best performance in the long run. “The summit helped clarify that Charite will likely be first, with ProDisc right behind it. But no one's saying who's best yet. All we know is that all the products are better than fusion.”
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