Acticon Neosphincter

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Overview

The Acticon® Neosphincter is the only implantable sphincter available for the treatment of severe fecal incontinence. Using the same technology that has been used for 30 years to treat urinary incontinence, the Acticon Neosphincter simulates normal sphincter function to give the patient control over defecation through a pressurized system.

The Acticon prosthesis can be implanted in both men and women with a pressure regulating balloon placed in the prevesical space, the cuff implanted around a segment of the anal canal, and the pump positioned in either the scrotum or the labium.

Features and Benefits

Pressure Regulating Balloon
The pressure regulating balloon is implanted in the prevesical space. This component controls the amount of pressure exerted by the occlusive cuff on the anal canal.

Occlusive Cuff
The cuff is implanted around a segment of the anal canal. When inflated, the cuff occludes the anal canal by applying circumferential pressure. The cuff opens under patient control and refills automatically following defecation.

AMS provides 12 cuff sizes for the Acticon prosthesis, with cuff lengths ranging from 9.0 cm to 14.0 cm and two cuff widths, including narrow (2.0 cm) and standard (2.9 cm).

Control Pump
Implanted in the soft tissue of the scrotum or labium, the control pump contains the resistor and valves needed to transfer fluid to and from the cuff. The control pump features a deactivation option so the cuff can be deflated for a prolonged period of time, as well as a septum port so fluid can be added to the system without additional surgery.

The control pump comes in one size that accommodates all cuff and balloon sizes.

Benefits

The Acticon Neosphincter offers many benefits for you and your patients:

Simulates normal sphincter function
Is easily controlled by the patient
Has proven clinical efficacy^1,2,3,4
Offers you a simple and reproducible procedure⁴
Significantly improves quality of life^1,3,5

1. U.S. FDA Premarket Approval P010020, December 18, 2001.
2. O'Brien P, et al. Restoring control: the Acticon Neosphincter Artificial Bowel Sphincter in the treatment of anal incontinence. Diseases of the Colon and rectum. 2000; 43:1213-1216.
3. Devesa J, et al. Artificial anal sphincter: complications and functional results of a large personal series, Diseases of the Colon and Rectum. 2002; 45(9):1154-1163.
4. Michot F, et al. Artificial anal sphincter in severe fecal incontinence: outcome of prospective experience with 37 patients in one institution. Accepted for publication in Annals of Surgery.
5. Lehur P, et al. Comparison of quality of life and anorectal function after artificial sphincter implantation. Disease of the Colon and Rectum. 2002; 45:508-513