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Innovata gets FDA approvable letter for Adept adhesion reduction solution
By Angela McDaniels
Seattle, June 1 - Innovata plc has received a letter from the Food and Drug Administration that says the company's Adept adhesion reduction solution is approvable for use as an adjunct to good surgical technique for the reduction of post-surgical adhesions in patients undergoing gynecological laparoscopic adhesiolysis, according to a company news release.
The letter further states that the FDA is continuing to review the product labeling and that Innovata must submit amended label copy for adverse event data and warnings and agree to proposals for post-approval safety monitoring. Innovata said it plans to submit this information as quickly as possible.
On March 27, Adept received a unanimous recommendation for marketing approval by the Obstetrics and Gynecology Devices Panel of the FDA.
Adept is a 4% icodextrin solution that has been used in adhesion reduction in more than 100,000 surgical patients in Europe since 2000.
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, according to the release.
The company said that pelvic and abdominal adhesions are a significant women's health issue as they can be associated with infertility, small bowel obstruction and chronic pelvic pain and that the use of anti-adhesion products has been limited by their difficulty in use and lack of clinical efficacy data.
Adept is licensed to Baxter International Inc. and is marketed by Baxter's BioSurgery business.
Innovata is based in Nottingham, England, and develops pulmonary products to treat respiratory disorders and other serious diseases.
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