Dispute Resolution Panel MeetingSept 6, 2001

Intergel® Adhesion Prevention Solution

Introduction to

FDA Presentations

FDA Review Team

• Elisa HarveyInfection Studies (ODE)• Roxi Horbowyj Clinical (ODE)• David Kaplan Manufacturing (OST)• Richard Kotz Statistics (OSB)• David Krause Lead/Preclinical (ODE)• Diane Mitchell OB/Gyn Clinical (ODE)

ODE Presenters

• Overview and Introduction - David Krause

• Clinical Review - Roxi Horbowyj

• Statistical Review - Richard Kotz

Indications Based on Same IDE Data Set in PMA Submissions

• Indications for Use as Originally Proposed

• INTERGEL® Adhesion Prevention Solution is indicated for use as an intraperitoneal instillate for reduction of adhesions following peritoneal cavity surgery. It has been shown to reduce the incidence, extent and severity of adhesions throughout the abdominal cavity when used as an adjunct to good surgical technique.

Indications Based on Same IDE Data Set in PMA Submissions

• Current Indications for Use Based on Previous and Subsequent Analyses

• Intergel solution is a single use, intra-peritoneal instillate indicated to reduce the likelihood of developing moderate or severe post-operative adenexal adhesions in patients undergoing adhesiolysis or myomectomy during conservative gynecological pelvic surgery by laparotomy, when used as an adjunct to good surgical technique. Intergel solution was also shown to reduce adhesion reformation to sites in addition to the adenexa, and adhesion formation at surgical sites, including the anterior abdominal wall.

FDA’s Question• Does the PMA as amended provide a reasonable

assurance of the safety and effectiveness of Intergel for its intended use as an intraperitoneal instillate for reduction of adhesion formation following gynecologic pelvic surgery?In answering this question the Panel should determine:– Whether the statistically significant differences

between Intergel Solution and control can be considered to be clinically significant?

– Do the benefits of the product outweigh the potential risks, including any risk of infection?