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c. GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE)

GORE® EXCLUDER® AAA Endoprosthesis

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GORE® EXCLUDER® AAA Endoprosthesis - Gore Medical

“Since completing the initial clinical trial, we have made one modification to the GORE EXCLUDER AAA Endoprosthesis design by adding a low-permeability film layer to the graft,” said Ryan Takeuchi, Aortic Business Unit Leader at Gore. “Requiring so few changes to the graft is unprecedented, yet we have strived to broaden the applicability and value to more patients by expanding the portfolio of sizes, reducing profile, and introducing an innovative, repositionable deployment system.”

GORE® EXCLUDER® Iliac Branch Endoprosthesis Gains …

W. L. Gore and Associates, Inc. submitted an application for new technology add-on payments for the GORE® EXCLUDER® Iliac Branch Endoprosthesis (GORE IBE device) for FY 2017. The device consists of two components: The Iliac Branch Component (IBC) and the Internal Iliac Component (IIC). The applicant indicated that each endoprosthesis is pre-mounted on a customized delivery and deployment system allowing for controlled endovascular delivery via bilateral femoral access. According to the applicant, the device is designed to be used in conjunction with the GORE® EXCLUDER® AAA Endoprosthesis for the treatment of patients requiring repair of common iliac or aortoiliac aneurysms. When deployed, the GORE IBE device excludes the common iliac aneurysm from systemic blood flow, while preserving blood flow in the external and internal iliac arteries.

GORE® EXCLUDER® Iliac Branch Endoprosthesis …

GORE ® EXCLUDER ® AAA Endoprosthesis

Gore is dedicated to post-market surveillance and monitoring long-term device performance in an effort to improve patient outcomes. With more than 3,000 patients enrolled in the Gore Global Registry for Endovascular Aortic Treatment (GREAT), data has been collected since August 2010 on patients treated with the GORE EXCLUDER AAA Endoprosthesis as well as the GORE® TAG® Thoracic Endoprosthesis, Conformable GORE TAG Thoracic Endoprosthesis, and most recently, the GORE® EXCLUDER® Iliac Branch Endoprosthesis. A total of 5,000 consecutive patients from up to 300 worldwide sites will be enrolled in the registry, and their treatment results will be tracked for 10 years.

The GORE EXCLUDER AAA Endoprosthesis is a minimally invasive treatment option for patients with abdominal aortic aneurysms (AAA), designed with active infrarenal fixation and engineered to provide migration resistance. The device also features exceptional limb performance due to the unique combination of ePTFE graft material and fully supported, nested, nitinol stent design to prevent kinking and occlusion. A presentation at the 2015 Vascular Annual Meeting featured a meta-analysis of several endovascular aneurysm repair (EVAR) devices that showed the GORE EXCLUDER Device limbs have the lowest incidence of occlusion at both one and three years.**

GORE® EXCLUDER® Conformable AAA Endoprosthesis …

16/07/2014 · AAA repair using Gore Excluder endoprosthesis ..

Dr. Oderich: Yes, whenever possible. This was a question that was not addressed in the trial, as extension of the branch device into divisional branches was an exclusion criteria. I believe these patients benefit from iliac branches because occlusion of the divisional branches by coil embolization is associated with very high rates of hip claudication. Moreover, these patients have few to no options to improve their disabling symptoms.

The cost of Iliac branch stent grafts impacts the overall costs of the EVAR procedure for the implanting hospital. In the United States, facilities using the GORE EXCLUDER Iliac Branch Endoprosthesis 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). This should improve hospital payments and align better with costs of using this new technology. The panelists also suggested that the cost of embolization may not be less expensive and, in some cases, could be more expensive with additional procedures and the cost of multiple coils. The cost of complications related to hypogastric occlusion, such as claudication and other sequelae, must also be considered. It may be suggested that long-term costs related to negative clinical outcomes (e.g., readmissions or additional treatments or appointments to monitor complications) with embolization or other alternate techniques may ultimately make the IBE a more cost-efficient option. The panelists suggested that a study to look at the cost effectiveness of hypogastric occlusion versus preservation may be important to support the benefits of iliac branch stent grafts.

GORE® EXCLUDER® AAA Endoprosthesis - Arteriae
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  • Catalogue Numbers for GORE® EXCLUDER® AAA Endoprosthesis

    GORE® EXCLUDER® Conformable AAA Endoprosthesis Receives Approval for Clinical Study in the US and Japan

  • Endoprotesis GORE EXCLUDER AAA de Gore Medical - …

    announced the first implants in Japan of the GORE® EXCLUDER® Iliac Branch Endoprosthesis

  • Gore Excluder AAA Repair - YouTube

    Photo - Riassunto: L'FDA approva l'endoprotesi per la branca iliaca GORE EXCLUDER Business Wire

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With regard to the newness criterion, the applicant received pre-market FDA approval of the GORE IBE device on February 29, 2016. The applicant submitted a request for an unique ICD-10-PCS procedure code and was granted approval for the following procedure codes to describe the use of this technology: 04VC0EZ (Restriction of right common iliac artery with branched or fenestrated intraluminal device, one or two arteries, open approach); 04VC0FZ (Restriction of right common iliac artery with branched or fenestrated intraluminal device, three or more arteries, open approach); 04VC3EZ (Restriction of right common iliac artery with branched or fenestrated intraluminal device, one or two arteries, percutaneous approach); 04VC3FZ (Restriction of right common iliac artery with branched or fenestrated intraluminal device, three or more arteries, percutaneous approach); 04VC4EZ (Restriction of right common iliac artery with branched or fenestrated intraluminal device, one or two arteries, percutaneous approach); 04VC4FZ (Restriction of right common iliac artery with branched or fenestrated intraluminal device, three or more arteries, percutaneous endoscopic, approach); 04VD0EZ (Restriction of left common iliac artery with branched or fenestrated intraluminal device, one or two arteries, open approach); 04VD0FZ (Restriction of left common iliac artery with branched or fenestrated, intraluminal device, three or more arteries, open approach); 04VD3EZ (Restriction of left common iliac artery with branched or fenestrated intraluminal device, one or two arteries, percutaneous approach); 04VD3FZ (Restriction of left common iliac artery with branched or fenestrated intraluminal device, three or more arteries, percutaneous approach); 04VD4EZ (Restriction of left common iliac artery with branched or fenestrated intraluminal device, one or two arteries, percutaneous endoscopic approach); and 04VD4FZ (Restriction of left common iliac artery with branched or fenestrated intraluminal device, three or more arteries, percutaneous endoscopic approach). These new ICD-10-PCS procedure codes became effective on October 1, 2016. After evaluation of the newness, costs, and substantial clinical improvement criteria for new technology add-on payments for the GORE IBE device and consideration of the public comments we received in response to the FY 2017 IPPS/LTCH PPS proposed rule, we approved the GORE IBE device for new technology add-on payments for FY 2017 (). With the new technology add-on payment application, the applicant indicated that the total operating cost of the GORE IBE device is $10,500. Under § 412.88(a)(2), we limit new technology add-on payments to the lesser of 50 percent of the average cost of the device or 50 percent of the costs in excess of the MS-DRG payment for the case. As a result, the maximum new technology add-on payment for a case involving the GORE IBE device is $5,250.

Assessment of the GORE® EXCLUDER® Conformable …

The GORE EXCLUDER AAA Endoprosthesis is a minimally invasive treatment option for patients with abdominal aortic aneurysms (AAA), designed with active infrarenal fixation and engineered to provide migration resistance. The device also features exceptional limb performance due to the unique combination of ePTFE graft material and fully supported, nested, nitinol stent design to prevent kinking and occlusion. A presentation at the 2015 Vascular Annual Meeting featured a meta-analysis of several endovascular aneurysm repair (EVAR) devices that showed the GORE EXCLUDER Device limbs have the lowest incidence of occlusion at both one and three years. (Photo: Business Wire)

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