From Reuters, May 24:
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The first approval was for the BAK1 system, or "titanium cage," made by Spine-Tech of Minneapolis, MN. It is recommended for use with autologous bone graft. Spine-Tech reported that, in a study of 946 patients, there was a 70% success rate in essential spinal fusion and improvement in patients' pain levels and levels of function following surgery.
The FDA Orthopedics & Rehabilitation Devices Panel voted 7 to 1 for approval, based on the company's fulfillment of a number of conditions. Among them: the company must perform a post-marketing study with follow-up for five years, develop a patient decision-making brochure or video and conduct a patient satisfaction survey on treatment outcomes.
The second approval was for the Ray Threaded fusion cage, manufactured by a division of U.S. Surgical in Norwalk, CT. The FDA panel similarly voted 7 to 1 for approval, and U.S. Surgical must meet some of the same conditions stipulated for Spine-Tech, such as the post-marketing study. In a 24-month trial of 21 patients, U.S. Surgical reported a 92% success rate in terms of spinal fusion.
Thus far, there are no histological studies on the effects of the Ray Threaded device. There are also no data on how much of a load patients with this device can bear. For both devices, the long-term effects are not known, nor is it known how difficult either of these devices are to remove.
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How can US Surgical expect approval with only 21 patients in the trial? That's obscenely inadequate.
Scott:
What's your take on the 70% success rate. Does this thing have to be removed for the 30%? Does the patient end up worse off than before?
Again, Thanks
Bruce |
