Study shows Strattice TM is safe for single-stage hernia repair

Oct 6 2010

Kinetic Concepts, Inc. (NYSE: KCI) today announced that its LifeCell™ Strattice™ Reconstructive Tissue Matrix (TM) achieved highly favorable one-year outcomes in an ongoing clinical study of single-stage repair of contaminated or infected ventral incisional hernias. This data represents the only prospective multicenter evidence published to date supporting the use of a product in a single-stage repair of difficult hernias and demonstrates that Strattice™ TM has been used as a safe and effective alternative to a two-stage or synthetic mesh repair.

“The results of this study are particularly encouraging because they demonstrate convincingly that Strattice™TM can be safely used for single-stage hernia repair in patients who would otherwise likely need to endure multiple operations.”

One-year interim results of the ongoing 80-patient Strattice™ Repair of Infected or Contaminated Abdominal Incisional Hernias (R.I.C.H.) study were released today in a scientific poster at the American College of Surgeons 96^th Annual Clinical Congress in Washington, D.C.

The study reported that surgeons using Strattice™ were able to achieve safe, definitive single-stage closure in more than 80 percent of patients with challenging (infected or contaminated) ventral hernias. Of equal significance, despite the occurrence of expected surgical site events such as seroma and wound infection in a number of patients, none required explants of the Strattice™ Tissue Matrix.

"Single-stage synthetic mesh repair of infected or contaminated hernias is associated with a poor outcome, often necessitating the complete removal of the mesh from the patient," according to principal investigator Dr. Kamal Itani, chief, surgical service, Boston VA Healthcare System and professor of surgery, Boston University. "As evidenced by this study, using Strattice™ Tissue Matrix allowed for single stage repair and resulted in no mesh explant; as such, it should be given serious consideration by surgeons as a valuable alternative to the use of two-stage repair or synthetic mesh products in treating patients with contaminated and infected incisional hernias."

Strattice™TM consists of a terminally sterilized sheet of the processed porcine dermal matrix provided in prescribed geometric configurations and packaged in a double pouch configuration. Use of Strattice™TM provides for an implant that is strong, biocompatible and allows for cell and microvascular ingrowth to remodel Strattice™TM into host tissue.

"Infected hernias are a challenge not only for physicians, but for patients who have to live with them," said Dr. Ronald P. Silverman, KCI's Chief Medical Officer. "The results of this study are particularly encouraging because they demonstrate convincingly that Strattice™TM can be safely used for single-stage hernia repair in patients who would otherwise likely need to endure multiple operations."

Ventral hernias—in these cases, incisional hernias—and their recurrences are commonly understood complications of abdominal surgery. They affect an estimated 400,000 people in the U.S. annually and may be regarded as some of the most complex and difficult hernias to treat. Ventral hernias presenting with infection or in a contaminated space are particularly challenging. The risk of infection is particularly high when synthetic mesh products are used in these repairs.

Since its introduction in the U.S. in 2008, Strattice™TM has become a surgical mesh of choice for many of America's leading surgeons desiring an alternative to synthetic mesh. It is used in a growing number of plastic, reconstructive, and general surgical procedures, including complex hernias, post-mastectomy breast reconstruction, mastopexy, and stoma reinforcement.

Dr. Itani will also present the study results later this week at the International Congress of the European Hernia Society in Istanbul.