BioSurgery Advancing Surgery, Enhancing Life

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Clinical Studies

ADEPT® Adhesion Reduction Solution [4% Icodextrin]

ADEPT®Adhesion Reduction Solution is indicated for use intraperitoneally as an adjunct to good surgical technique for the reduction of post-surgical adhesions in patients undergoing gynecological laparoscopic adhesiolysis.

Important ADEPT® Safety Information

For more information, please refer to the ADEPT® Adhesion Reduction Solution [4% icodextrin] Instructions for Use.

ADEPT® is the first FDA-cleared device for adhesion reduction in gynecologic laparoscopic surgery. The pivotal study was the first double-blind, randomized controlled clinical trial in adhesion reduction.2

ADEPT® has been studied in the USA in two pilot studies and one double-blind pivotal study in female patients undergoing gynecological laparoscopic surgery with a planned second look laparoscopy.

Studied in 3 randomized, controlled, multicenter US clinical trials

In the sub-group of patients presenting with a primary diagnosis of infertility, significantly more infertility patients (52.9%) had a reduction in AFS score compared with the LRS group (30.4%) p=0.001. Not adjusted for multiplicity.1

Pivotal Study: 1st and 2nd look Laparascopy
Intraoperative Photos in the ADEPT® Treatment Group

1st Look Laparoscopy, Pre-Adhesiolysis of Right Tubo-Ovarian Adhesions
Pre-Adhesiolysis of Right Tubo-Ovarian Adhesions

2nd Look Laparoscopy, Status Post Right Tubo-Ovarian Adhesiolysis
Status Post Right Tubo-Ovarian Adhesiolysis

1st Look Laparoscopy, Pre-Adhesiolysis of Left Adnexal Adhesions
Pre-Adhesiolysisof Left Adnexal Adhesions

2nd Look Laparoscopy, Status Post Adhesiolysis of Left Adnexal Adhesions
Status Post of Left Adnexal Adhesions

1st Look Laparoscopy, Pre-Adhesiolysis of Right Ovarian Fossa Adhesions
Pre-Adhesiolysisof Right Ovarian Fossa Ahdesions

2nd Look Laparoscopy, Status Post Adhesiolysis of Right Ovarian Fossa Adhesions
Status Post Adhesiolysis of Right Ovarian Fossa Adhesions

Significantly more patients in the ADEPT® group, 49% versus the LRS group, 38% (P=.018) were classified as a clinical success* in the per protocol population (n=402).2

*Clinical success was defined as a reduction in adhesions of at least 3 or 30% of sites lysed (whichever was greater) between the initial surgery and the follow-up laparoscopy.2

ADEPT® compared to Saline and Glucose3

Intraperitoneal volume chart
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References

  1. ADEPT® Adhesion Reduction Solution [4% icodextrin] Instructions for Use, 6208501EH01.
  2. Brown C., Luciano A., Martin D., Peers E., et al. Adept (icodextrin 4% solution) reduces adhesions after laporoscopic surgery for adhesiolysis: a double-blind, randomized controlled study. Fertility and Sterility, In Press, Corrected Proof, Available online 26 March 2007.
  3. Hosie K., Gilbert J.A., Kerr D., Brown C.B., Peers EM. Fluid dynamics in man of an intraperitoneal drug delivery solution: 4% icodextrin. Drug Deliv 2001; 8: 9-12.