FLAGSTAFF, Ariz. and WASHINGTON, D.C. (June 5, 2015) – W. L. Gore & Associates (Gore) today announced the results of a two-year clinical quality improvement (CQI) study, with Surgical Momentum, examining an improved methodology in evaluating GORE® DUALMESH® Biomaterial in laparoscopic repair for ventral hernia patients. The presentation of findings, titled, “The Real World Doesn’t Have A Protocol: Challenging the Paradigm of Clinical Research,”¹ took place today at the Abdominal Wall Reconstruction Conference 2015 in Washington, D.C.

Traditional clinical research relies on specific inclusion and exclusion criteria to establish a patient population that is controlled and strives to reduce variability and complexity in the protocol. Clinical quality improvement consists of systematic and continuous actions that lead to measurable improvement in health care services and the health status of targeted patient groups. Gore and Surgical Momentum launched the CQI study in 2012, focusing on the use of GORE® DUALMESH® Biomaterial and its potential to improve physician experiences and patient outcomes.

“Gore Medical’s commitment to patients led them to perform this clinical quality improvement study, which was applied at a local level allowing us to understand how to measure value across the patient’s entire cycle of care,” said Dr. Bruce Ramshaw, Director of Advanced Hernia Solutions. “Using the principles of CQI, the local clinical team has the ability to include the patient and family in a shared decision process without limiting patient options and process improvement ideas while studying real-world clinical outcomes.”

Hernia repair is the most common surgery performed worldwide, with ventral hernia repairs in the US estimated to cost at least $3.2 billion annually.² Patients with recurrences and other complications may undergo repeated surgeries to repair the abdominal wall and prevent re-herniation. Co-morbidities, such as obesity, smoking, and diabetes mellitus may contribute to the complexity of the surgery. A previous study found every reduction in hernia recurrence resulted in substantial cost savings – each one percent reduction would save around $32 million annually.³

“Enhancing patient outcomes is at the core of everything we do,” said Ron Anderson, General Medical Products, Business Leader for Gore. “Examining GORE® DUALMESH® Biomaterial for hernia repair in real world applications shows the value this new methodology brings in demonstrating how technologies such as GORE® DUALMESH® Biomaterial improves lives and saves the healthcare system significant costs.”

“It has been exciting to work on this project over the last three years, through long-term follow up and see such positive outcomes for both the patient and Gore,” said Kevin D. Jackson, Surgical Momentum’s President and CEO. “This is a perfect example of why we bring providers like Advanced Hernia Solutions and medical product companies together to collect clinical and cost data for a specific surgical procedure, analyze that data and share the analysis back with both collaborators for process and product improvement activities.”

GORE® DUALMESH® Biomaterial is a soft, conformable, ePTFE material that offers a unique, two-surface design intended for hernia repair and other applications. The biomaterial features two functionally distinct surfaces: the textured CORDUROY® Surface encourages host tissue incorporation while the smooth surface minimizes tissue attachment to the material.

The clinical reputation of GORE® DUALMESH® Biomaterial for the repair and reconstruction of ventral hernias is well known, exceeding 150 peer-reviewed scientific articles published since 1996 and more than 19 years of clinical history. GORE® DUALMESH® Biomaterial is approved for use worldwide.

¹ Ramshaw B. The real world doesn’t have a protocol: challenging the paradigm of clinical research. Presented at the Abdominal Wall Reconstruction (AWR) Meeting; June 4-6, 2015; Washington, DC.

² Poulose BK, Shelton J, Phillips S, et al. Epidemiology and cost of ventral hernia repair: making the case for hernia research. Hernia2012;16(2):179-183.

³ Carbonell AM II, Chao JJ, Cobb WS IV, et al. H.E.R.N.I.A.: hernia experts roundtable and new innovations assembly—expert consensus on the use of biosynthetic and biologic mesh in hernia repair. Special report. General Surgery News 2014;41(3):1-8.

Surgical Momentum, LLC is a Healthcare Data Analytics firm. The company brings a specialized knowledge that allows the healthcare community to service patients better, more economically, and with better outcomes. Surgical Momentum provides data analysis and solutions in a context that defines, measures and improves outcomes for all stakeholders within the medical profession. Surgical Momentum’s collection of real world data from surgeons, hospitals, and academic medical centers is analyzed and used to improve decisions, patient outcomes, and reduce costs. The company facilitates collaboration between providers, pharmaceutical, and medical device companies.

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 U.S. “100 Best Companies to Work For” lists since the rankings debuted in 1984. For more information, visit www.goremedical.com.

GORE®, DUALMESH®, CORDUROY and designs are trademarks of W. L. Gore & Associates.

Chempetitive Group for W. L. Gore & Associates
Kena Hudson or Rachel Wallace
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