The secondary effectiveness endpoints, according to Mr del Castillo, consisted of all the primary endpoint components, listed previously, which are pain in function as measured by ODI, device failures requiring a revision, re-operation or removal, any major complications and neurological status.
A Danish surgeon, Dr Andre van Ooij, also testified at the hearing, and advised the panel about the known complications associated with the Charite, and provided the members with visual slides showing the adverse events that occurred in a number of patients.
Dr van Ooij tracked hundreds of surgeries in Europe and in eight years, he treated 49 Charite patients, 28 women and 28 men, with some their surgeries performed as early as 1989. All of these patients, he noted, suffered terrible leg and back pain after the device was implanted and many were unable to undergo a surgical revision of the disc due to the dangers involved in spinal surgery.
Dr van Ooij also advised that some men implanted with the device suffered retrograde ejaculation and erectile dysfunction, and others patients suffered leg complications and joint degeneration.
"One big issue that was not spoken about today," he pointed out, "is breakage of the metal wire."
"If you look good at the x-rays," he advised the panel while showing a slide, "you can see the breakage and the flattening of the polyethylene core and probably also some wear debris."
Overall, more than half of the patients in Europe ended up with fair or poor results after the disc was implanted.
Orthopedic and spine surgeon, John Peloza, also testified at the hearing and told the panel that first and foremost, the Charite disc had to last the lifetime of the patient and that the average age of a person that would be a candidate for the procedure is about the mid-40s.
"I think it is critical that these implants last for the life of the patients," he said, "because revision surgery to remove the implant particular from an anterior approach will be potentially life threatening in every case."
"And at present," he advised, "there is no consistently successful strategy to deal with a failed implant."
"I don't think the polyethylene as they have in this implant will last anywhere near 40 years or the lifetime of the patient," he advised.
In addition, he said the fixation of the disc to the bone was compromised.
"The metal base is secured with a press fit with little spikes," he explained. "This is not adequate and will predictably fail," he added.
There are published studies, he told the panel, that show significant re-operation rates between 5 and 20 percent with complication rates reported greater than 10 percent.
As for results in regard to pain relief, the clinical studies in Europe and Australia, he said, essentially report results equivalent to fusion in regard to pain relief.
After listening to all the testimony about the dangers of the Charite disc, in the end, the FDA advisory panel's vote for approval of Charite was unanimous.
A Danish surgeon, Dr Andre van Ooij, also testified at the hearing, and advised the panel about the known complications associated with the Charite, and provided the members with visual slides showing the adverse events that occurred in a number of patients.
Dr van Ooij tracked hundreds of surgeries in Europe and in eight years, he treated 49 Charite patients, 28 women and 28 men, with some their surgeries performed as early as 1989. All of these patients, he noted, suffered terrible leg and back pain after the device was implanted and many were unable to undergo a surgical revision of the disc due to the dangers involved in spinal surgery.
Dr van Ooij also advised that some men implanted with the device suffered retrograde ejaculation and erectile dysfunction, and others patients suffered leg complications and joint degeneration.
"If you look good at the x-rays," he advised the panel while showing a slide, "you can see the breakage and the flattening of the polyethylene core and probably also some wear debris."
Overall, more than half of the patients in Europe ended up with fair or poor results after the disc was implanted.
Orthopedic and spine surgeon, John Peloza, also testified at the hearing and told the panel that first and foremost, the Charite disc had to last the lifetime of the patient and that the average age of a person that would be a candidate for the procedure is about the mid-40s.
"I think it is critical that these implants last for the life of the patients," he said, "because revision surgery to remove the implant particular from an anterior approach will be potentially life threatening in every case."
"And at present," he advised, "there is no consistently successful strategy to deal with a failed implant."
"I don't think the polyethylene as they have in this implant will last anywhere near 40 years or the lifetime of the patient," he advised.
In addition, he said the fixation of the disc to the bone was compromised.
"The metal base is secured with a press fit with little spikes," he explained. "This is not adequate and will predictably fail," he added.
There are published studies, he told the panel, that show significant re-operation rates between 5 and 20 percent with complication rates reported greater than 10 percent.
As for results in regard to pain relief, the clinical studies in Europe and Australia, he said, essentially report results equivalent to fusion in regard to pain relief.
After listening to all the testimony about the dangers of the Charite disc, in the end, the FDA advisory panel's vote for approval of Charite was unanimous.
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