FDA 审议团支持用于阻止不可控制的肠道活动的设备(下)
"I urged the use of it as a treatment of last resort because the device has such a high complication rate. But short of this, I think it's a good choice," explained Dr. Karen Woods, in a subsequent interview with Reuters Health. Woods is a committee member and a clinical professor at Baylor College of Medicine in Houston, Texas.
Common adverse events included pain, infections and the thinning of the skin or tissue over the implant. In total, 34 patients also eventually had to have the device surgically removed due to various adverse events.
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But patients that suffer from severe fecal incontinence generally become socially isolated due to the fear of suffering from an unintended bowel movement, Dr. Douglas Wong, an associate professor of medicine at Cornell University Medical School and a principal investigator of the clinical trial, told committee members. As a result, Wong and his colleagues said that the high rate of adverse events and removals is acceptable if patients understand the risks.
The committee members agreed, noting that those patients with successful implants seemed to experience a dramatic improvement in their quality of life.
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In the clinical trial, about 89% of the patients said that they had no ability to regulate their bowel movements prior to the implant compared with 9% of those patients with a successful implant after one year.
However, the committee also said that the approval should be conditional upon the company developing a training program for physicians and limiting its use to those patients 18 years and older.
"In summary, the majority opinion of the committee is that it is safe and effective when used in the patient population in which it was studied," concluded Dr. Mark Talamini, a committee member and assistant professor of surgery at Johns Hopkins University School of Medicine in Baltimore, Maryland.
, http://www.100md.com
The vote now means that the FDA is likely to approve the device. Although the agency is not bound by its committees' votes, the agency generally does follow their advice.
If the FDA should approve the device, then the US will be following in the footsteps of Europe, Australia and China, where the device already has been approved.
But in the end, the device is unlikely to generate any significant revenues for American Medical Systems. The company needed 4 years just to recruit the 115 patients in the US trial.
In Friday trade on the NASDAQ, shares in American Medical Systems declined 0.05 to close at 19.95., 百拇医药
Common adverse events included pain, infections and the thinning of the skin or tissue over the implant. In total, 34 patients also eventually had to have the device surgically removed due to various adverse events.
, 百拇医药
But patients that suffer from severe fecal incontinence generally become socially isolated due to the fear of suffering from an unintended bowel movement, Dr. Douglas Wong, an associate professor of medicine at Cornell University Medical School and a principal investigator of the clinical trial, told committee members. As a result, Wong and his colleagues said that the high rate of adverse events and removals is acceptable if patients understand the risks.
The committee members agreed, noting that those patients with successful implants seemed to experience a dramatic improvement in their quality of life.
, 百拇医药
In the clinical trial, about 89% of the patients said that they had no ability to regulate their bowel movements prior to the implant compared with 9% of those patients with a successful implant after one year.
However, the committee also said that the approval should be conditional upon the company developing a training program for physicians and limiting its use to those patients 18 years and older.
"In summary, the majority opinion of the committee is that it is safe and effective when used in the patient population in which it was studied," concluded Dr. Mark Talamini, a committee member and assistant professor of surgery at Johns Hopkins University School of Medicine in Baltimore, Maryland.
, http://www.100md.com
The vote now means that the FDA is likely to approve the device. Although the agency is not bound by its committees' votes, the agency generally does follow their advice.
If the FDA should approve the device, then the US will be following in the footsteps of Europe, Australia and China, where the device already has been approved.
But in the end, the device is unlikely to generate any significant revenues for American Medical Systems. The company needed 4 years just to recruit the 115 patients in the US trial.
In Friday trade on the NASDAQ, shares in American Medical Systems declined 0.05 to close at 19.95., 百拇医药