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

By Debra Sherman

SAN FRANCISCO (Reuters) - Johnson & Johnson's (JNJ.N: Quote, Profile, Research) 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.

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.