This structure, which is designed to replace a tracheal segment, must be sufficiently rigid to support the proximal insertion of a neosphincter
that opens during respiration and closes during the passage of a food bolus and, at best, would include phonatory capabilities.
The gracilis neosphincter
operation is no longer performed in North America, Dr.
American Medical Systems (AMS), Minnetonka, MN, announced an FDA advisory panel has recommended approval of its Acticon Neosphincter
, an implantable device designed to imitate the function of the sphincter muscle and help prevent uncontrolled bowel movements.
AMS), approval to market in the United States the company's new humanitarian device, the Acticon(TM) Neosphincter
, for the treatment of severe fecal incontinence.
Food and Drug Administration (FDA) today provided Pre-Market Approval for the Acticon(R) Neosphincter
from American Medical Systems (Nasdaq:AMMD).
When surgical treatment is warranted, options include occlusion, sphincteroplasty, neosphincter
, radio-frequency energy, and fecal diversion.
The Acticon Neosphincter
is another device that is gaining popularity for surgical treatment of fecal incontinence.
Chronic diarrhea or constipation must be corrected before the Acticon neosphincter
goes in, explained Dr.
Only 11% of participants were able to defer defecation preoperatively, compared with more than 80% postoperatively Perhaps most impressive was the finding that more than 70% of patients rated their quality of life favorably following receipt of the Acticon neosphincter
, compared with just 19% before.
Artificial anorectal sphincters (Acticon neosphincter
by American Medical Systems, Minneapolis) were implanted in 19 patients between May 1996 and May 2000 at a single institution.
The mean score among neosphincter
users fell from 105 at baseline--indicative of daily incontinence--to 48 at 1 year, which equates to seepage only.
No adverse lifestyle alterations were reported by 700/n of patients with the neosphincter
, said Dr.