Innovata Adept adhesion product gets FDA panel recommendation

By Elaine Rigoli

Tampa, Fla., March 28 - Innovata plc announced Tuesday that its Adept adhesion reduction solution, for use in obstetric and gynecologic surgery, received a unanimous recommendation for marketing approval by the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee of the Food and Drug Administration.

The FDA advisory panel has recommended Adept as a surgical adjunct for the reduction of post-surgical adhesions in patients undergoing gynecologic laparoscopic surgery, which includes adhesiolysis, according to a company news release.

An adhesion is a band of scar tissue that binds two planes of tissue together that should remain separate. Studies suggest that adhesions may form in more than 10% of patients who have never had surgery and in 93% of patients having abdominal or pelvic surgery.

Pelvic and abdominal adhesions can be associated with infertility, small bowel obstruction and chronic pelvic pain.

Available in Europe since 2000, Adept is a 4% icodextrin solution that has been used in adhesion reduction in more than 100,000 surgical patients, the release said.

The phase 3 study supporting Innovata's filing submission was conducted in more than 400 patients undergoing gynecological laparoscopic adhesiolysis in the United States.

The results showed that Adept reduced the number of adhesions following surgery as well as reduced pain scores, while the overall incidence of adverse events in the Adept and control groups was similar, the release said.

Adept is licensed to Baxter International Inc. and is marketed by Baxter's BioSurgery business.

Innovata, with headquarters in Nottingham, United Kingdom, develops pulmonary products to treat respiratory disorders and other serious diseases.

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