Final study results of bioabsorbable mesh shows significant
improvement in patient quality of life while offering cost-savings to
hospitals and payors
FLAGSTAFF, Ariz.--(BUSINESS WIRE)--W.
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L. Gore & Associates, Inc. (Gore) today announced final results
of a long-term, prospective, multicenter study evaluating the use of GORE®
BIO-A® Tissue Reinforcement, a bioabsorbable mesh, in complex
ventral hernia (CVH) repair in patients with contaminated fields.
Michael Rosen, MD, Cleveland Clinic, the lead investigator of the study,
published the research in the Annals of Surgery.
Patients scheduled to undergo CVH repair often have a poor quality of
life preoperatively because of a GI fistula, mesh infection, or
non-healing abdominal wound. With a sample size of more than 100
patients, these study results showed improved quality of life and a
favorable hernia recurrence rate of only 17 percent after 24 months when
using the GORE BIO-A Tissue Reinforcement. Typically, in this type of
patient population, the recurrence rate is as high as 39 percent with a
biologic mesh. Additionally, by using in lieu of a permanent, synthetic
mesh, the GORE BIO-A Tissue Reinforcement lessens long-term
complications in part because it does not necessitate removal of the
mesh.
“I think this study represents an important step forward in defining the
most appropriate way to reconstruct complex abdominal wall defects,”
said Dr. Rosen. “Bio A [GORE BIO-A Tissue Reinforcement] performed very
well in this challenging group of patients and will provide a
cost-effective alternative for reconstructive surgeons.”
GORE BIO-A Tissue Reinforcement is a uniquely designed web of
biocompatible synthetic polymers that is gradually absorbed by the body,
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.
GORE BIO-A Tissue Reinforcement, as a biosynthetic mesh, also provides
cost savings over a biologic mesh that has 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.
“This study proves for the first time something we have believed all
along: a biosynthetic mesh can be equivalent or better than a biologic,”
said Ron Anderson, General Surgical Products Business Unit Leader. “By
being both more cost effective for hospitals and payors while also
improving quality of life for patients, GORE BIO-A Tissue Reinforcement
is truly advancing healthcare and the way we treat CVH.”
Annals of Surgery, the world’s most highly referenced surgery
journal, provides the international medical community with information
on significant contributions to the advancement of surgical science and
practice. Surgeons look to Annals of Surgery first for
innovations in practice and technique. Special editorial features
include “Advances in Surgical Technique,” which provides
up-to-the-minute coverage of current clinical issues, and monthly review
articles that cover the most current practice concerns.
ABOUT US
At Gore Medical, we have provided creative therapeutic solutions to
complex medical problems for 40 years. During that time, 40 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 U.S. “100 Best Companies to Work For” lists since
the rankings debuted in 1984. For more information, visit www.goremedical.com.
GORE® and BIO-A® are trademarks of W. L. Gore & Associates.
Contacts
Chempetitive Group for W. L. Gore & Associates
Andrea Vuturo,
(858) 457-2436