Say goodbye to incontinence
Release date: 2015-12-22
Fecal incontinence is an uncontrollable peristalsis of the intestines. This is a common problem that is often underestimated, especially in older people. The most common cause of fecal incontinence is damage to the muscles around the anus (anal sphincters), from diseases such as vaginal delivery or dysfunction, such as diabetes.
William Maisel, MD, Acting Director of the FDA's Device and Radiation Health Center's Equipment Evaluation Office, said that 'non-invasive treatment of fecal incontinence, such as medications, dietary changes and other medical measures, sometimes does not adequately address the patient's symptoms, when other methods are not When it comes to improving the quality of life of patients, the Fenix ​​system offers a viable option to deal with this situation'.
The Fenix ​​system has three components: an implant, an anal sphincter adjustment tool, and an introducer tool. The implant is a series of magnetic powder core titanium beads connected by a titanium wire to form a ring shape. The attraction of the magnetic beads enhances the movement of the anal sphincter, minimizing the involuntary opening of the anal canal and reducing the likelihood of severe fecal incontinence. The implant device is provided in a number of sizes to accommodate changes in sphincter size. The adjustment tool is used to correlate to the appropriate implant to accommodate the size of the anal sphincter. The adjustment tool used by the introducer tool to import the position.
Through the Humanitarian Equipment Exemption (HDE) process, the FDA reviewed data from the Fenix ​​system. Humanitarian use of equipment (HUD), which is treated or diagnosed, is beneficial to patients, and in the United States, there are fewer than 4,000 such patients each year. Because equipment manufacturers' research and development costs may far exceed their market returns, HUD provides FDA with appropriate incentives to develop equipment used in treatment or disease diagnosis and treatment that affects these populations.
35 cases of conventional drug treatment failure in the treatment of fecal incontinence were studied using the Fenix ​​System. The study evaluated the procedure before and after the procedure and the effects of six weeks, three months, six months and 12 months after implantation. Five years after being implanted, the United States will have an annual assessment report for 15 participants.
A validated, disease-specific questionnaire was used to quantify changes in quality of life in terms of quality of life called fecal incontinence, and after the Fenix ​​system was implanted, the intestinal incontinence was tracked by using the intestinal diary. After 12 months, 62.9% of participants were reduced by half or more in the number of fecal incontinence episodes; 54.3% experienced a reduction in fecal incontinence days by half or more; and 37.1% of emergency episodes were reduced by half or more . Participants also showed measures to improve quality of life, including depression, self-awareness and emotional improvement. These results indicate that fecal incontinence can benefit from Fenix ​​system equipment when patients have no other treatment for fecal incontinence.
The Fenix ​​system should not be implanted in patients who are intolerant to titanium or known to be allergic to titanium. Adjustment tools and introducer tools should also not be used in patients who are intolerant to titanium or allergic to titanium, stainless steel, nickel or ferrous materials.
Implants are considered to be magnetically unsafe. After implantation, the patient should not be exposed to a magnetic resonance imaging (MRI) environment like it can interfere with the strength of the magnetic field and the function of the device.
Adverse events found in clinical trials include pain, infection, caulking or defecation disorder, device erosion, device removal/restart, and bleeding.
FDA permits marketing of fecal continence restoration system
Source: Yaodu Net
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