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Friday August 17 5:25 PM ET
FDA Panel Backs Artificial Sphincter Device
WASHINGTON (Reuters Health) - Expert advisors to the US Food and Drug Administration (news - web sites) (FDA) endorsed on Friday the approval of a novel implantable device designed to imitate the function of the sphincter muscle and help prevent uncontrollable bowel movements.
The FDA Gastroenterology and Urology Devices Panel voted 7 to 1 in favor of recommending the approval of American Medical System's Acticon Neosphincter, a silicone-based prosthesis consisting of a balloon and control pump.
The device was designed to imitate the sphincter muscle by allowing patients to open the anal canal using the control pump to inflate the balloon.
The device already is available under a humanitarian device exemption, which allows it to be used as a treatment of last resort. But the vote of the committee is significant because insurance companies often refuse coverage for devices under investigation, and at present there are no treatment options for patients who fail to respond to traditional treatments such as diet changes, medications or surgery.
Still, the device is likely to remain a treatment of last resort even if the FDA should follow its committee's recommendation and approve the device.
In the pivotal clinical trial submitted to support the Minnetonka, Minnesota-based concern's device, there were a total of 395 device-related adverse events among the 115 participating patients, leading committee members to urge that the device be limited only to the most severe cases.
``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.
But patients that suffer from severe fecal incontinence generally become socially isolated due to the fear of suffering an unintended bowel movement, Dr. Douglas Wong, an associate professor of medicine at Cornell University Medical School and a principal investigator for the clinical trial, assured committee members. As a result, Wong and his colleagues said, this high rate 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.
In the clinical trial, about 89% of the patients said they had no control over their bowel movements prior to the implant compared to 9% of those patients with a successful implant after one year.
However, the committee also said 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.
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. To recruit just the 115 patients to the US trial took the company almost 4 years.
http://dailynews.yahoo.com/h/nm/20010817/hl/sphincter.html
FDA Panel Backs Artificial Sphincter Device
WASHINGTON (Reuters Health) - Expert advisors to the US Food and Drug Administration (news - web sites) (FDA) endorsed on Friday the approval of a novel implantable device designed to imitate the function of the sphincter muscle and help prevent uncontrollable bowel movements.
The FDA Gastroenterology and Urology Devices Panel voted 7 to 1 in favor of recommending the approval of American Medical System's Acticon Neosphincter, a silicone-based prosthesis consisting of a balloon and control pump.
The device was designed to imitate the sphincter muscle by allowing patients to open the anal canal using the control pump to inflate the balloon.
The device already is available under a humanitarian device exemption, which allows it to be used as a treatment of last resort. But the vote of the committee is significant because insurance companies often refuse coverage for devices under investigation, and at present there are no treatment options for patients who fail to respond to traditional treatments such as diet changes, medications or surgery.
Still, the device is likely to remain a treatment of last resort even if the FDA should follow its committee's recommendation and approve the device.
In the pivotal clinical trial submitted to support the Minnetonka, Minnesota-based concern's device, there were a total of 395 device-related adverse events among the 115 participating patients, leading committee members to urge that the device be limited only to the most severe cases.
``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.
But patients that suffer from severe fecal incontinence generally become socially isolated due to the fear of suffering an unintended bowel movement, Dr. Douglas Wong, an associate professor of medicine at Cornell University Medical School and a principal investigator for the clinical trial, assured committee members. As a result, Wong and his colleagues said, this high rate 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.
In the clinical trial, about 89% of the patients said they had no control over their bowel movements prior to the implant compared to 9% of those patients with a successful implant after one year.
However, the committee also said 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.
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. To recruit just the 115 patients to the US trial took the company almost 4 years.
http://dailynews.yahoo.com/h/nm/20010817/hl/sphincter.html
