Torax Medical said today that the 1st U.S. implantation of its Fenix magnetic continence restoration system was performed late last week.
The Fenix system is made up of a series of magnetic titanium beads that are implanted in the anal sphincter to minimize the involuntary opening of the anal canal. The system comes with a tool to size the implant and a tool to guide the implant and sizing tool into position.
The procedure was carried out at Jacksonville, Fla.’s Mayo Clinic by Dr. Paul Pettit, the St. Paul, Minn.-based company said.
“Currently, if patients are not happy with their quality of life after conservative and less invasive therapy, the only surgical option that stands between them and a colostomy is the newly-available Fenix device. Here at the Mayo Clinic, we are excited to be able to offer this new treatment to our patients,” Dr. Pettit said in a prepared statement.
In January, Torax its Fenix system won FDA Humanitarian Device Exemption approval for treating fecal incontinence.
The FDA announced the device had been cleared for marketing in mid-December, with indications for treating fecal incontinence in patients who are not candidates for, or have failed with other options to treat the issue.