10:16 uur 05-01-2016

CORRECTIE en VERVANGING Nu gepubliceerd in de Annals of Surgery: Langetermijnresultaten positief over effectiviteit van GORE BIO-A Tissue Reinforcement bij behandeling complexe littekenbreuk

FLAGSTAFF, Ariz.–(BUSINESS WIRE)– Vervang het eerdere persbericht alstublieft door de volgende gecorrigeerde, op meerdere punten aangepaste versie.


W. L. Gore & Associates, Inc. (Gore) heeft vandaag de resultaten gepresenteerd van een langdurig, prospectief en in meerdere centra uitgevoerd onderzoek naar het biosynthetische gaas GORE® BIO-A® Tissue Reinforcement voor de behandeling van een complexe littekenbreuk bij patiënten met vervuilde wonden. De resultaten van het onderzoek onder leiding van Michael Rosen van de Cleveland Clinic is geaccepteerd voor publicatie in de Annals of Surgery.

Patiënten die een herstellende operatie voor littekenbreuk ondergaan hebben voorafgaand aan de operatie vaak een lage kwaliteit van leven, wegens een gastro-intestinale fistel, infectie door gaas of een niet helende wond in de onderbuik. De resultaten van dit onderzoek, waarvoor zich meer dan honderd patiënten hadden aangemeld, wezen op een verbeterde kwaliteit van leven en intacte genezingen bij 83 procent van de patiënten bij gebruik van GORE BIO-A Tissue Reinforcement. Doorgaans ligt het terugvalcijfer bij dit type patiënt, die zijn behandeld met biologisch gaas, op 30 procent. Onderzoekers rapporteerden dat geen enkel biosynthetisch gaas volledig moest worden gewijzigd als gevolg van een infectie.



CORRECTING and REPLACING Now Published in the Annals of Surgery: Long-Term Favorable Results Demonstrate GORE BIO-A Tissue Reinforcement Efficacy in Complex Ventral Hernia Repairs

FLAGSTAFF, Ariz.–(BUSINESS WIRE)– Please replace the release with the following corrected version due to multiple revisions.

This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20160104005412/en/

GORE® BIO-A® Tissue Reinforcement. (Photo: Business Wire)GORE® BIO-A® Tissue Reinforcement. (Photo: Business Wire)

The corrected release reads:


Final study results demonstrate for the first time efficacy of long-lasting absorbable biosynthetic mesh in challenging hernia repairs; has potential to end biologics era in hernia repair

W. L. Gore & Associates, Inc. (Gore) today announced final results of a long-term, prospective, multicenter study 1 evaluating the use of GORE ® BIO-A ® Tissue Reinforcement, a biosynthetic mesh, in complex ventral hernia (CVH) repair in patients with contaminated wounds. Results of the study led by lead investigator Michael Rosen, MD, Cleveland Clinic, was accepted for publication in the Annals of Surgery.

Patients and physicians interested in learning more about the study can view the paper here.

Patients scheduled to undergo CVH repair often have a poor quality of life preoperatively because of a gastrointestinal fistula, mesh infection, or non-healing abdominal wound. With more than 100 patients enrolled, these study results showed improved quality of life and intact hernia repairs in 83 percent of patients when using GORE BIO-A Tissue Reinforcement. Typically, in this type of patient population, the recurrence rate is as high as 30 percent 2 with a biologic mesh. The investigators reported that no biosynthetic required complete removal due to infection.

“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, as a biosynthetic mesh, also provides cost savings over a biologic mesh. Biologic mesh is often more expensive than biosynthetic mesh due to the complexity of harvesting tissue from cadavers or animal sources, as well as the subsequent processing and storage requirements to avoid the risks of viral contamination.

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  biosynthetic 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.

“This study demonstrates for the first time something we have believed all along: a biosynthetic mesh offers specific advantages when compared with a biologic mesh,” 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.


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.

  1. Rosen M, Bauer JJ, Harmaty M, et al. Multicenter, prospective, longitudinal study of the recurrence, surgical site infection, and quality of life after contaminated ventral hernia repair using biosynthetic absorbable mesh: the COBRA Study. Annals of Surgery. In press.
  2. Rosen M, Carbonell A, Cobb W, et al. Multicenter prospective longitudinal trial evaluating recurrence, surgical site infection and quality of life after contaminated ventral hernia repair using biosynthetic absorbable mesh. Presented at the 1st World Conference on Abdominal Wall Hernia Surgery; April 25-29, 2015; Milan, Italy. Hernia 2015;19(2)Supplement 2:S106. CO16:03.

GORE ® and BIO-A ® are trademarks of W. L. Gore & Associates.


Chempetitive Group for W. L. Gore & Associates
Andrea Vuturo, (858) 457-2436

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