FortaGen^®

For tissue repair, FortaGen^® material heals tissue defects where initial strength is required and replacement with host tissue is desired.

The FortaGen^® product comes in three and five layers for the indications of hernia and prolapse and in eight layers for the rotator cuff indication (CuffPatch™) for increased strength. It has a low level of collagen crosslinking. It is designed for applications that require initial strength for repair, followed by remodeling and replacement by host tissue (e.g., vaginal prolapse, cystocele, rectocele, abdominal hernias).

Vaginal prolapse is a condition caused by the protrusion (herniation) of a pelvic organ such as the bladder, small bowel organs, rectum into the vaginal area. When the muscles around the organ are weakened, for example due to childbirth, they can cause the organs to drop into the vaginal wall. There are various types of vaginal prolapse. For example, cystocele is the protrusion of the bladder into the vaginal wall and rectocele is the protrusion of the rectum into the back wall of the vagina.

Studies demonstrate that FortaGen^® constructs with a low level of collagen crosslinking:

• Begin to infiltrate with cells by 30 days post-implant
• Are substantially remodeled by 6 months
• Are well-integrated at the suture line (provides a lasting graft-host tissue interface not dependent on permanent sutures)
• Do not elicit a foreign body response
• Are as strong as adjacent host tissue at
  360 days
• Do not re-herniate