FDA Clearance and Device Listing
Neurogenic Bowel Patient Population Information Sheets
Peristeen Clinical Studies
Neurogenic Bowel Clinical Guidelines
Reviews on Fecal incontinence and Constipation in Adults
Indication: The Peristeen® Transanal Irrigation System is intended to instill water into the colon through a rectal catheter, which incorporates an inflatable balloon, inserted into the rectum to promote evacuation of the contents of the lower colon. The Peristeen Transanal Irrigation System is indicated for use by children (2 years - <12 years old), adolescent (12 years - < 18 years old), transitional adolescent (18 - <21 years old) and adult patients with neurogenic bowel dysfunction who suffer from fecal incontinence, chronic constipation, and/or time-consuming bowel management procedures.
Contraindications: Peristeen Transanal Irrigation must not be used in the following situations: known anal or colorectal stenosis, colorectal cancer, radiotherapy to the pelvis, and recent abdomino-perineal surgery, active inflammatory bowel disease, acute diverticulitis, severe diverticulitis, previous diverticulitis and diverticular abscess, chronic symptomatic diverticular disease, within 3 months of abdominal, anal or colorectal surgery, within 4 weeks of endoscopic polypectomy, recent colonic biopsy, recent endoscopic mucosal resection (EMR) and recent endoscopic sub-mucosal dissection (ESD), severe autonomic dysreflexia, ischemic colitis, during Spinal cord shock phase, or complex diverticular disease, in patients who are pregnant and have not used the system before*. Since the list is not exhaustive, the healthcare professional should always consider individual patient factors as well.
*If the patient is pregnant and has never used anal irrigation before, they should not start the irrigation procedure during pregnancy.
Warning: Peristeen Transanal irrigation procedure should always be carried out with care. Bowel perforation is an extremely rare, but serious and potentially lethal complication to transanal irrigation and will require immediate admission to a hospital, often requiring surgery. See the device manual for complete user instructions, contraindications, warnings, precautions, and potential complications/adverse events. For further information, call Coloplast Corp at 1-855-605-7594 or consult the company website at www.coloplast.us. Caution: Federal law restricts this device to sale by or on the order of a physician.
Prior to use, refer to product labeling for complete product instructions for use, contraindications, warnings and precautions.