Baxter, Innovata get FDA approval for Adept adhesion reduction solution

By Elaine Rigoli

Tampa, Fla., Aug. 1 - Baxter Healthcare Corp. and Innovata plc announced that the Food and Drug Administration has approved Adept Adhesion Reduction Solution for use in gynecological laparoscopic procedures in the United States.

Adept, a 4% icodextrin solution that has been used for adhesion reduction in Europe since 2000, has been studied in three randomized, controlled U.S. clinical trials involving 548 patients undergoing gynecological laparoscopic surgery with a follow-up laparoscopic procedure after the initial procedure.

For the patients in the Adept group, 45.4% were defined as a "clinical success" compared to 35.6% in the control group, according to a news release.

Clinical success was defined as a decrease in the number of adhesions between the first and second laparoscopies, the release said.

Patients in the Adept group had significantly fewer sites with adhesions at second-look compared to first-look adhesiolysis laparoscopy.

Developed by Innovata, Adept is licensed to Baxter on a global basis. Baxter's biosurgery business will launch Adept in the United States in the fourth quarter. Baxter's BioSurgery business develops and commercializes biosurgery products used in the areas of hemostasis, tissue sealing and tissue repair.

Innovata, based in Nottingham, England, develops pulmonary products for the treatment of respiratory disorders and other serious diseases.

Baxter, the principal U.S. operating subsidiary of Baxter International, Inc., is based in Deerfield, Ill.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.