Health Highlights: Dec. 21, 2015
New Fecal Incontinence Treatment Approved by FDA Wearable Heart Defibrillator Approved for Children
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
New Fecal Incontinence Treatment Approved by FDA
A system to treat people who can't control their bowel movements (fecal incontinence) has been approved by the U.S. Food and Drug Administration.
Fecal incontinence is a common but underreported problem, especially among older adults the FDA said. A common cause is damage to the muscles around the anal sphincter from vaginal childbirth or diseases such as diabetes.
The Fenix Continence Restoration System was approved for use in patients who cannot receive, or have not responded to, surgery or other types of treatment, the FDA said.
The system includes a ring-shaped implant consisting of titatnium beads with magnetic cores that are connected by titanium wires. The magnetic attraction between the beads assists the anal sphincter in order to reduce the opening of the anal canal and the risk of severe fecal incontinence.
"Non-invasive treatment options for fecal incontinence, such as drugs, dietary changes and other medical measures, sometimes don't adequately address a patient's symptoms," Dr. William Maisel, acting director, Office of Device Evaluation, FDA Center for Devices and Radiological Health, said in an agency news release.
"The Fenix System affords a viable surgical option to address this condition when other methods have failed to improve a patient's quality of life," he added.
Wearable Heart Defibrillator Approved for Children
A wearable heart defibrillator for children at risk of potentially deadly sudden cardiac arrest has been approved by the U.S. Food and Drug Administration.
The LifeVest device is approved for certain youngsters who are at risk for sudden cardiac arrest, but can't be given implantable heart defibrillators due to medical reasons or because they're parents won't permit it.
Automated external defibrillators are available in many public places, but LifeVest is the only one that is worn by the patient and constantly monitors the wearer for abnormal, life-threatening heart rhythm problems, the FDA said.
When needed, LifeVest automatically delivers a shock to restore normal heart rhythm.
"The pediatric medical community is often forced to use adult devices off-label without appropriate labeling or instructions for use in pediatric patients," Dr. Vasum Peiris, chief medical officer of Pediatrics and Special Populations in the FDA's Center for Devices and Radiological Health, said in an agency news release.
"Doctors now have important information that may help them safely prescribe this life-saving device to young patients who may benefit from the device," Peiris added.
LifeVest -- made by Pittsburgh-based ZOLL Manufacturing Corp. -- weighs less than two pounds and consists of two main components: an electrode belt and garment that go around the chest, and a monitor the patient wears around the waist.
The device is meant for children who weight at least 41 pounds and have a chest size of 26 inches or more, about the size of an average 8-year-old, the FDA said.
The device was already approved for people 18 and older.