ADEPT®
The Burden of Postoperative Adhesions
20-40% infertility cases caused by adhesions
The percentage of cases of infertility in women that are caused by adhesions1
#1 cause of secondary infertility
Cause of secondary infertility in women1
34.5 % of patients re-admitted due to adhesions
Patients were admitted almost twice (1.9 times) for a problem potentially related to adhesions or for further surgery potentially complicated by adhesions over a 10-year period2
Results based on Clinical Studies
Simple and Effective
Direct and Fast-Acting Application
As a liquid, ADEPT® is administered directly and rapidly to the site through a laparoscopic port during surgery3
Broad Coverage and Optimized Resorption
Ingredient icodextrin slows the resorption time, whereas regular fluids would be resorbed much faster5
PAMELA Study
Double-blind randomized controlled trial comparing ADEPT® (n=203) and Lactated Ringer's Solution (n=199) during laparoscopic gynecological surgery6
Ariel Registry
Pan European registry of ADEPT® use in 2,069 gynecologic patients7
Rated most frequently by surgeons as "good" or "excellent" in both laparoscopy and laparotomy cohorts
Can be used without requiring significant changes in surgical practice
Considered easy to use by participating surgeons
Overall satisfaction with ADEPT® as good or excellent in >90% of procedures
ADEPT® Adhesion Reduction Solution [4% Icodextrin] Indications
Important Risk Information for ADEPT®
ADEPT® is intended for use as an intraperitoneal instillate for the reduction of adhesions following gynecological laparoscopic surgery, and should be used as the irrigant during the course of that surgery.
ADEPT® is indicated to be used in gynecological laparoscopic surgery of the abdominal-pelvic cavity in adults.
Contraindications
ADEPT® is contraindicated:
- In patients with known or suspected allergy to cornstarch based polymers, icodextrin, maltose or isomaltose intolerance, or in patients with glycogen storage disease.
- In the presence of frank infection (e.g. peritonitis) in the abdomino-pelvic cavity.
- In procedures with laparotomy incision. Serious post-operative wound complications including dehiscence and cutaneous fistula formation have been reported from clinical experience when ADEPT® was used in surgical cases with laparotomy incision.
- In procedures involving bowel resection or repair, or appendectomy. Anastomotic failure, ileus, peritonitis and rare cases of serosal fibrosis following procedures involving bowel resection and instillation of ADEPT® have been reported from clinical experience.
There are rare reports of pleural effusion from clinical experience with ADEPT®. As a possible relationship to the use of ADEPT®, in conjunction with inappropriate fluid monitoring during surgical procedure cannot be ruled out, the volume of ADEPT® instilled should always follow the recommendations of the Instructions for Use.
Self-limited vulvar swelling is a known side-effect of instilling large volumes of fluid into the abdomino-pelvic cavity. Most cases resolve within one week of surgery. When swelling is associated with urinary retention, catheterization may be necessary effects).
Maltose metabolites of icodextrin may interfere with blood glucose measurement in diabetic patients who use rapid blood glucose systems that are not glucose specific.
For safe and proper use of this device, please refer to full Instructions For Use.
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