I know this is an old article but I bolded the part I found interesting...I still don't understand why the FDA hasn't yet approved the single level arm of the study. Could Synthes actually asked them to hold off with final approval , until the 2 level arm was approved as well?
see
http://www.orthosupersite.com/defaul...=view&rid=5142
I've cut and pasted it below:
New artificial disc awaiting final FDA approval
Once approved, the ProDisc-L will be available in the United States for treating lumbar spine DDD at a single level from L3-S1.
1st on the web (January 9, 2006)
January 2006
Synthes Inc. has received a letter from the FDA notifying the company that its premarket approval application for the ProDisc-L total disc replacement is approvable pending an inspection of related manufacturing facilities, the company announced.
If approved, this will be only the second artificial disc to receive marketing clearance in the United States as an alternative to fusion for single-level degenerative disc disease (DDD).
The ProDisc-L is awaiting final FDA approval as an alternative treatment for lumbar spine DDD at a single level from L3-S1.
COURTESY: SYNTHES INC.
The FDA based its decision on the results of a clinical trial conducted over four years with 292 patients at 17 sites. The study compared the efficacy of ProDisc-L to circumferential fusion on outcomes such as pain and disability, neurologic status, and maintenance or improvement of flexion-extension/range of motion at the index level. Patients were followed for two years postop, according to a press release.
The FDA will issue its approval order for the company’s PMA after it completes and reviews an inspection of Synthes’ Brandywine, Pa., manufacturing facility. Peter Fehlmann, an official in the investor relations department at Synthes, told Orthopedics Today that the FDA has not yet scheduled an inspection date. “We are waiting for it, and it is basically a date that the FDA will decide upon,” he said.
Despite the “approvable” letter from the FDA, Fehlmann noted that the company cannot release study data until it receives the final approval order.
With final approval the ProDisc-L will be available in the United States as an alternative treatment for lumbar spine DDD at a single level from L3-S1. The company is also considering seeking approval for additional indications.
“We did conduct a second arm to the study, which is for multi-level procedures or two-level procedures.
But we will first wait for the approval order for the single-level device and then also take into consideration the overall market environment before we decide on how we want to progress with the PMA for the multi-level procedure,” Fehlmann said.
The ProDisc-L is currently available in most European countries as well as some countries in Asia.