OMEN
09-20-2006, 07:51 AM
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Medtronic's Prestige spinal disc is a safe and effective replacement for degenerated discs in the neck area and should be approved, a US advisory panel said.
Medtronic is seeking Food and Drug Administration approval for the device, which is designed as an alternative to spinal fusion surgery. The panel, which voted unanimously in favor of the device, added that approval should come with certain conditions such as further long-term studies.
The FDA will make the final approval decision, but usually follows the advice of its panelists.
Medtronic also has filed with the FDA seeking approval for a related disc called Bryan. The FDA only sought advice from the panel of outside experts on Prestige.
If either is approved, it would be the first artificial disc available for patients with degenerative disc disease affecting the neck area called the cervical spine.
Overall, the panel agreed with the company that data showed the device worked and was safe, at least in the short term.
"I do think this device has promise," said panelist Dr. John Kirkpatrick, a University of Alabama orthopedic surgeon.
Still, several panelists expressed concern about the disc itself, questioning why Medtronic chose stainless steel instead of stronger cobalt and chrome used for other devices such as artificial hips. They also questioned what would happen to the device over time.
Shares of Minneapolis-based Medtronic earlier closed down 3 cents at US$46.49 on the New York Stock Exchange.
Reuters
Medtronic's Prestige spinal disc is a safe and effective replacement for degenerated discs in the neck area and should be approved, a US advisory panel said.
Medtronic is seeking Food and Drug Administration approval for the device, which is designed as an alternative to spinal fusion surgery. The panel, which voted unanimously in favor of the device, added that approval should come with certain conditions such as further long-term studies.
The FDA will make the final approval decision, but usually follows the advice of its panelists.
Medtronic also has filed with the FDA seeking approval for a related disc called Bryan. The FDA only sought advice from the panel of outside experts on Prestige.
If either is approved, it would be the first artificial disc available for patients with degenerative disc disease affecting the neck area called the cervical spine.
Overall, the panel agreed with the company that data showed the device worked and was safe, at least in the short term.
"I do think this device has promise," said panelist Dr. John Kirkpatrick, a University of Alabama orthopedic surgeon.
Still, several panelists expressed concern about the disc itself, questioning why Medtronic chose stainless steel instead of stronger cobalt and chrome used for other devices such as artificial hips. They also questioned what would happen to the device over time.
Shares of Minneapolis-based Medtronic earlier closed down 3 cents at US$46.49 on the New York Stock Exchange.
Reuters