New Technology Add-On Payment Awarded For W. L. Gore & Associates EXCLUDER Iliac Branch Endoprosthesis

Recognition of new technology status will provide additional hospital reimbursement for IBE when used in FDA approved indications

FLAGSTAFF, Ariz.--(BUSINESS WIRE)--W. L. Gore & Associates, Inc. (Gore) today announced the U.S. Centers for Medicare and Medicaid Services (CMS) has granted the GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE) new technology status. Beginning October 1, 2016, facilities using the IBE in conjunction with a GORE® EXCLUDER® AAA Device for endovascular aneurysm repair (EVAR) are eligible for a new technology add-on payment (NTAP) of up to $5,250 per case, in addition to the applicable base payment for the Medicare Severity Diagnosis-Related Group (MS-DRG).

“Since receiving FDA approval, the IBE has experienced rapid adoption among physicians wanting to ensure their patients have access to the best therapies and treatment options available through technological innovation”

Recognition of new technology status is based on meeting three criteria. The technology must 1) be a new device and / or application; 2) demonstrate substantial clinical benefit to the patient; and 3) have an associated cost not already represented in the current rate base. NTAP payments are made for no less than two and no more than three years, after which the DRG base rates are adjusted to reflect facility-reported costs and the utilization rate of the new technology.

Gore was also successful in a previous petition to Medicare for the reclassification of EVAR, creating two new DRGs with increased hospital base reimbursement effective federal fiscal year (FFY) 2016. This NTAP, along with the DRG base increase resulting from the FFY 2016 DRG reclassification, will greatly improve the alignment of hospital payment and average resource consumption, making sure hospitals are more appropriately compensated for using this new technology.

Built on Gore’s technology platform and designed using their proven and durable expanded polytetrafluoroethylene (ePTFE) graft and nitinol stent materials, the IBE is used in conjunction with the GORE EXCLUDER AAA Device to preserve blood flow to the external iliac and internal iliac arteries. Preserving blood flow to these arteries is the recommended treatment by vascular societies to sustain quality of life.^{1, 2}

“Prior to the IBE, there were limited options for maintaining blood flow to the internal iliac arteries during endovascular aneurysm repair, which is a consideration in about 25 percent of AAA cases,” said Brian Peterson, MD, Vascular Surgeon at St. Anthony’s Medical Center in St. Louis. “The IBE provides physicians with an FDA-approved, off-the-shelf system to preserve blood flow to the internal iliac arteries and maintain patient quality of life.”

Implanted more than 2,500 times worldwide, the IBE is specifically designed for the endovascular treatment of common iliac artery and aortoiliac aneurysms. This complete, fully engineered system (Gore designed iliac branch and internal iliac components) received CE Mark in 2013, was registered in Australia and New Zealand in 2015, and gained FDA and Health Canada approval in February 2016.

“Since receiving FDA approval, the IBE has experienced rapid adoption among physicians wanting to ensure their patients have access to the best therapies and treatment options available through technological innovation,” said Ryan Takeuchi, Aortic Business Unit Leader at Gore. “The decision by CMS to support the new tech add-on payment is recognition of the significance of the IBE in providing a solution for a previously unmet need in endovascular aortic repair.”

The IBE is part of the growing GORE® EXCLUDER® Device family that shares a mission to effectively treat aortic aneurysms through minimally invasive means and is backed by Gore’s highly rated clinical support team, comprehensive educational offerings, and a wealth of clinical data.

1, 2 For the complete list of references, visit goremedical.com/IBE

ABOUT W. L. GORE & ASSOCIATES

At Gore, 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.

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