Adept® Adhesion Reduction Solution (4 percent Icodextrin) - P050011
This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: Adept® (4% Icodextrin) Adhesion Reduction Solution
PMA Applicant: Innovata plc
Address: 104a West Street, Farnham, Surrey, GU9 7EN, United Kingdom
Approval Date: July 28, 2006
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf5/p050011a.pdf
What is it? Adept® Adhesion Reduction Solution (4% Icodextrin) is a pale yellow fluid that contains icodextrin. The fluid is used during or after laparoscopic gynecological surgery to separate and protect tissues and decrease the number of new adhesions after surgery. Adept® is supplied sterile, in a single-use bag.
How does it work? During surgery, and/or at the end of surgery, the tissues in the abdomen are covered with the Adept® fluid to provide a temporary, physical separation of the tissue surfaces during the early phases of the natural healing process.
When is it used? Adept® is used in patients undergoing laparoscopic gynecological surgery (surgery on the female reproductive organs, e.g., ovaries, uterus, fallopian tubes) to reduce the amount or severity adhesions (scar tissue that binds together normally separate tissues) in the abdomen. The fluid is used during surgery and/or placed in the abdomen at the end of the surgery, to separate and protect tissues, decreasing the number of new adhesions after surgery.
What will it accomplish? Adept® will reduce the chance that a woman will develop adhesions following laparoscopic surgery. Adhesions are a common complication of gynecological surgery, and can be the cause of pelvic pain, bowel obstruction, or infertility.
When should it not be used? Adept® should not be used in patients
- with known or suspected allergy to cornstarch based polymers e.g., icodextrin, with maltose or isomaltose intolerance, or with glycogen storage disease;
- with frank infection (e.g. peritonitis) in the abdomino-pelvic cavity;
- in procedures involving laparotomy incision. (Serious post-operative wound complications including dehiscence and cutaneous fistula formation have been reported from clinical experience outside the US when Adept® was used in surgical cases with laparotomy incision);
- in procedures involving bowel resection or repair, or appendectomy. (Anastomotic failure, ileus and peritonitis following procedures involving bowel resection and instillation of Adept® have been reported from clinical experience outside of the US.)
Additional information: The Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p050011