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Use of the mcompass® Anorectal Balloon Expulsion Catheter is indicated when there is a need or suspicion of an anorectal disorder.

The mcompass® Anorectal Balloon Expulsion Catheter is used to perform a Balloon Expulsion Test (BET) to evaluate a patient's recto-anal functionality and coordination by simulating the presence of feces to evaluate muscular contractions of the rectum. Use of the mcompass® Anorectal Balloon Expulsion Catheter is indicated when there is a need or suspicion of an anorectal disorder.

The catheter is ~60cm in length and constructed as a single-lumen flexible shaft with an expandable balloon on the distal end and a stopcock for a closing mechanism on the proximal end. The shaft and balloon of the device is made of medical grade silicone rubbers.

The device is packaged and labeled as a single-use, non-sterile, disposable product.

BETs may be performed as a standalone test but are routinely performed along with an anorectal manometry examination. Procedurally, an empty and lubricated anorectal balloon expulsion catheter is inserted into the rectum. A syringe is filled with the desired volume of air or water, commonly 50-60 cc for adults, and connected to the catheter's luer fitting. The air or water is injected into the catheter causing the balloon to expand and simulate the presence of feces. The patient is sat on a toilet or commode and instructed to expel the balloon within a predetermined timeframe, often 60 seconds. The choice of air or water, volume of fill, and the timeframe for expulsion are at the discretion of the user.

Functionally, distention of the rectum, by balloon or feces, exerts pressure on the rectal wall which causes an autonomous nervous reflex response called the RectoAnal Inhibitory Reflex (RAIR). This involuntary reflex relaxes the internal anal sphincter, allowing for normal defecation.

The design of the mcompass® Anorectal Balloon Expulsion Catheter, including a firm yet pliable balloon, provides for meaningful distention at usual fill volumes to properly trigger RAIR and allow for normal expulsion by the patient, as if feces, for purposes of the BET.

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