Study Confirms GORE® BIO-A® Tissue Reinforcement a Proven Alternative to Biologics in Hernia Repair

Two-year study demonstrates improved patient satisfaction with Gore material

Flagstaff, Ariz. & Milan, Italy (April 28, 2015) — W. L. Gore & Associates, Inc. (Gore) today announced final results of a long term prospective multicenter study examining the quality of life for patients after complex ventral hernia (VH) repair. Investigators presented their findings in the Complex Open Bioabsorbable Reconstruction of the Abdominal Wall Study, focused on hernia repair with a biosynthetic mesh, at the 2015 World Hernia Conference in Milan, Italy. The biosynthetic GORE® BIO-A® Tissue Reinforcement was studied in hernia repair at nine centers in the US and Europe. Patients reported improved quality of life over time after complex VH repair with GORE® BIO-A® Tissue Reinforcement.

Patients scheduled to undergo complex VH repair often have a poor quality of life preoperatively because of a GI fistula, mesh infection, or non-healing abdominal wound. GORE® BIO-A® Tissue Reinforcement provides a unique material option for complex cases because it is designed with the ideal porosity for rapid cellular infiltration and vascularization to generate quality tissue fast.

GORE® BIO-A® Tissue Reinforcement is a uniquely designed web of biocompatible synthetic polymers that the body gradually absorbs, while its 3D matrix of open, highly interconnected pores facilitates tissue generation and healing.  As a synthetic tissue scaffold, it is not derived from human or animal tissue but engineered for uniformity, consistency and versatility. Clinical evidence demonstrates that the scaffold is replaced with favorable type I collagen, leaving no permanent material behind. GORE® BIO-A® Tissue Reinforcement is currently marketed in many countries worldwide.

Our study is possibly one of the first complex VH clinical studies of a 3D biosynthetic mesh to factor in patient satisfaction. With a three-year shelf life and no soaking, refrigeration or tracking required, this versatile material is the easy-to-use performance-proven alternative that offers value for surgeons and hospitals alike.

“This study represents an important step forward in defining the most appropriate way to reconstruct complex abdominal wall defects,” said Michael Rosen, MD, Cleveland Clinic. “GORE® BIO-A® Tissue Reinforcement performed very well in this challenging group of patients and will provide a cost effective alternative for reconstructive surgeons.”

Biologic hernia meshes have a high cost due to the harvesting of tissues from cadavers, pigs, cows, and then the subsequent processing to remove cells to protect patients from possible viral contamination. Most other synthetics, while less expensive, are a permanent addition to the patient’s body. The GORE® BIO-A® Bioabsorbable Material technology combines the best of the two hernia mesh treatment options, consistently created with no synthetic material left behind, and no risk of viral contamination from tissue-derived biologic materials.

“This disruptive technology introduces a new class of biosynthetic that simultaneously offers high patient satisfaction while saving hospitals and payers potentially significant amounts of money in what they spend on biologics each year for complex hernia repair and abdominal wall reconstruction,” said Ron Anderson, General Surgical Products Business Unit Leader at Gore.

ABOUT US

At Gore, we have provided creative therapeutic solutions to complex medical problems for more than 35 years. During that time, more than 35 million innovative Gore Medical Devices have been implanted, saving and improving the quality of lives worldwide. Our extensive family of products includes vascular grafts, endovascular and interventional devices, surgical meshes for hernia and soft tissue reconstruction, staple line reinforcement materials, and sutures for use in vascular, cardiac, and general surgery. We are one of a select few companies to appear on all of the US “100 Best Companies to Work For” lists since the rankings debuted in 1984.