FDA 审议团支持用于阻止不可控制的肠道活动的设备(上)
WASHINGTON (Reuters Health) - Expert advisors to the US Food and Drug Administration (FDA) endorsed on Friday the approval of a novel implantable device designed to imitate the function of the sphincter muscle, and in effect, helping 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., 百拇医药
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., 百拇医药