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Evidence & Reimbursement > Peristeen

FDA Clearance and Device Listing

Peristeen FDA Establishment Registration & Device Listing
K083770 FDA 510(k) Clearance and Summary (Original)
K140310 FDA 510(k) Clearance and Summary (Most Recent)

 

Product Information

Peristeen Transanal Irrigation IFU
Peristeen Transanal Irrigation Product Information
Peristeen rectal balloon catheter – product utilization

 

Neurogenic Bowel Patient Population Information Sheets

Patients affected by Neurogenic Bowel Dysfunction
Neurogenic Bowel Dysfunction
Treatment Options for Neurogenic Bowel Dysfunction

 

Peristeen Clinical Studies

Peristeen Transanal Irrigation System Bibliography for Adults

 

Neurogenic Bowel Clinical Guidelines

PVA Guidelines, Paralyzed Veterans of America, Management of Neurogenic Bowel Dysfunction in Adults after Spinal Cord Injury
 To request a PDF of the 2020 Guidelines, request through the Paralyzed Veterans of America Website: https://info.pva.org/receive-your-pdf-of-pvas-neurogenic-bowel-cpg
  Coloplast Summary of PVA Guidelines for Management of Neurogenic Bowel Dysfunction in Adults after Spinal Cord Injury
NICE Guidance, National Institute for Health and Care Excellence, UK, Peristeen transanal irrigation system for managing bowel dysfunction
 To view NICE guidance, search for MTG 36 on the NICE website: https://www.nice.org.uk/guidance
  Peristeen Transanal Irrigation System to Manage Bowel Dysfunction: A NICE Medical Technology Guidance (open access)
This paper summarizes Cedar’s assessment report and how it was used to inform the NICE MTG 36 Guideline.

 

Reviews on Fecal incontinence and Constipation in Adults

AHRQ: Treatments for Fecal Incontinence. Comparative Effectiveness Review No. 165
Cochrane Database of Systematic Reviews: Management of faecal incontinence and constipation in adults with central neurological disease (Review)
Search for the title at: https://www.cochranelibrary.com/ and select view in PDF

 

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.

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