Innovata plc and Baxter Healthcare Corporation announced that US Food and Drug Administration (FDA) have approved ADEPTR Adhesion Reduction Solution for use in gynaecological laparoscopic procedures in the US.

ADEPT is indicated for use intraperitoneally, as an adjunct to good surgical technique for the reduction of post-surgical adhesions in patients, undergoing gynaecological laparoscopic adhesiolysis. ADEPT is a 4 per cent icodextrin solution, which has been used for adhesion reduction in Europe, since 2000.

ADEPT has been studied in three randomized, controlled US clinical trials involving a total of 548 patients undergoing gynaecological laparoscopic surgery with a follow-up (second look) laparoscopic procedure after the initial procedure.

In the pivotal study, for the patients in the ADEPT group, 45.4 per cent were defined as a "clinical success" compared to 35.6 per cent in the control group. Clinical success was defined as a decrease in the number of adhesions between the first (baseline) and second laparoscopies. Patients in the Adept group, had significantly (p=0.016) fewer sites with adhesions at second-look compared to first-look adhesiolysis laparoscopy.

Adhesions are abnormal attachments between tissues or organs. Gynaecological adhesions may cause pain, secondary infertility or other complications in women.

"This is a significant development for patients with adhesion-related disorders and the surgeons who are managing those patients," stated Thomas Lyons, MD, of Atlanta, GA, who served as one of the clinical investigators for the US trials. "This is currently the only product which has approval for laparoscopic use, making it doubly helpful since laparoscopic surgery is a better solution for adhesions, than traditional open surgery. As a gynaecologic surgeon who works in this area.

ADEPT is the first and only approved fluid-based approach for adhesion reduction in gynaecological laparoscopic adhesiolysis in the US.