From: Reuters
Published March 7, 2008 12:53 PM

J&J's spinal disc implant in for design changes

By Debra Sherman

SAN FRANCISCO (Reuters) - Johnson & Johnson's <JNJ.N> artificial spinal disc, launched in the United States with great fanfare three years ago, is in for design adjustments, the company said.

The Charite artificial lumbar disc was the first such device on the U.S. market, and the company and investors alike had high hopes for it.

But sales have been stalled by challenges in obtaining full reimbursement from the Centers of Medicare and Medicaid and insurance companies, and by debate about whether such implants help or hurt patients.

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Michael Mahoney, chairman of J&J's DePuy orthopedics group, said DePuy was "tweaking" the design of Charite but maintained the problem is not the product. The issue, he said, is in the company's inability to get full reimbursement amid a lack of clinical data.

"The great lesson for us for the future is to balance clinical data with reimbursement," Mahoney said in an interview at the American Academy of Orthopaedic Surgeons in San Francisco. "That was our shortfall. But it remains an important part of our portfolio."

The goal of disc replacement has been to treat painful degenerated lumbar discs. Disc replacement has been offered as an alternative to spinal fusion.

The Charite is made up of two small metallic endplates and a polyethylene core that moves between them.

The degenerated disc is removed and the cobalt chromium endplates are inserted in its place; one endplate is attached to the vertebra above, and the other to the vertebra below.

The polyethylene core is inserted between the plates to create a disc-like structure to mimic the normal disc by providing separation between the vertebrae and allowing the normal range of motion and flexibility for that segment of the spine.

Dr. Charles Rosen, a spine surgeon at UCI Medical Center in Orange County, California, contends the design of the Charite, as well as a competing disc made by the Swiss company Synthes Inc <SYST.VX>, is flawed.

"The center of rotation is wrong," said Rosen, who said he is currently treating 34 patients who have had problems with these implants.

Rosen, who testified before the U.S. Congress last week on the ethical conflict when surgeons are paid by industry as consultants, wrote in a paper evaluating disc failures: "The lack of a logical solution may have been reinforced with a financial disincentive to find one, given that the design had been accepted, applied and marketed at great expense to both industry and investors."

Mahoney said the fundamental design of the devices is right but could do with some "tweaks."

(Editing by John Wallace)

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