Endovascular prosthesis gore : Write good essay plan
GORE Carotid Stent W.L
Endovascular Repair of Aortic Aneurysms - Medical …
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.
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.
Strategies in the surgical treatment of type A aortic …
With regard to the first criterion, whether a product uses the same or a similar mechanism of action to achieve a therapeutic outcome, the applicant indicated that the GORE IBE device is based on the same design principles as other endovascular repair devices, and its use differs because of the specific target site for implantation. Consequently, it has a different shape and method of delivery from other endovascular devices. The GORE IBE device is similar to the GORE® EXCLUDER® AAA Endoprosthesis, primarily differing in device dimensions to fit within the iliac artery anatomy. With regard to the first criterion, we expressed concern in the FY 2017 IPPS/LTCH PPS proposed rule () that the GORE IBE device has a similar mechanism of action to other stenting grafts used to treat patients with abdominal aortic aneurysms (AAAs) because it repairs the abdominal aortoiliac aneurysm from the inside and is inserted in a similar manner to other abdominal aortoiliac endovascular aneurysm repair devices.
The TBE is part of the growing family of endovascular products that share a mission to effectively treat aortic disease, backed by Gore’s highly rated clinical support team and educational offerings. The comprehensive portfolio of products includes the first FDA approved off-the-shelf iliac branch device, the GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE), indicated for the endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms. To round out the branched portfolio, studies are ongoing in the U.S. and Brazil for the GORE® EXCLUDER® Thoracoabdominal Branch Device (TAMBE).
Aortoenteric fistula: Recognition and management - …
With regard to the second criterion, whether a product is assigned to the same or a different MS-DRG, the applicant indicated that cases using the GORE IBE device would map to the same MS-DRGs as cases involving other stent-grafts used to treat patients with AAAs. Specifically, similar to cases involving other stent-grafts used to treat AAAs, cases involving the GORE IBE device would be assigned to MS-DRG 268 (Aortic and Heart Assist Procedures except Pulsation Balloon with MCC) and MS-DRG 269 (Aortic and Heart Assist Procedures except Pulsation Balloon without MCC).
With regard to the third criterion, whether the new use of the technology involves the treatment of the same or similar type of disease and the same or similar patient population, the applicant indicated that the GORE IBE device is intended to be used in the treatment of patients requiring repair of common iliac or aortoiliac aneurysms. The applicant stated that this device, if approved, would be the first purpose-built endovascular device for patients whose conditions (common iliac or aortoiliac aneurysm) put them at risk for negative clinical outcomes due to limitations of current treatment methods, which may not preserve internal iliac artery perfusion. The applicant described current repair options for these patients as: (a) Intentional occlusion and coverage of the internal iliac artery; (b) undergoing a more extensive surgical operation to place a bypass graft; or (c) use of combinations of devices in a nonindicated, variable, and inconsistent manner. With regard to the third criterion, we expressed concern that this device appears to treat a similar type of disease to existing stent grafts.
Surgical operations – UFRGS – Inicial — UFRGS
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TheList_search - MRI Safety Home
Various endovascular therapeutic options exist fortreatment of RAAs. These options fall into two categories—embolization with metallic or liquid embolicmaterials and exclusion through stent grafts. Based onthe treatment options for RAA, Rundback et al proposedan angiographic classification system.13 Type I RAAs aresaccular and arise from either the main renal artery trunkor proximally from a large segmental artery. These can besuccessfully treated with stent grafts or stent/balloonassistedcoil embolization (Figure 1). Type II RAAs arefusiform, occur at the main renal artery or proximal segmentalarteries, and are best treated surgically (Figure 2).Type III RAAs refer to intraparenchymal aneurysmsaffecting the small segmental or accessory arteries. Theseare best treated with coil embolization with minimal lossof parenchyma (Figure 3). Successful embolization of theaneurysm while preserving the distal perfusion of thenormal parenchyma is preferable to prevent kidney dysfunction.
Endovascular treatment of popliteal artery aneurysm
Aortic arch disease has traditionally been difficult to treat. The options currently available for the treatment of these pathologies require complex procedures such as open surgery, a hybrid approach with surgical re-vascularization, or combination procedures that use devices in an off-label capacity. The limited options for these patients is one of the reasons that the TBE is the first Gore device to receive the new FDA Expedited Access Pathway (EAP) designation and among the first medical devices to receive this designation in the U.S. This pathway is limited to certain medical devices that demonstrate the potential to address unmet medical needs for life-threatening diseases and offer a meaningful patient benefit compared to existing alternatives.
and in four of these occlusion of the prosthesis ..
The purpose of this study is to assess the safety and effectiveness of the GORE® EXCLUDER® Iliac Branch Endoprosthesis (GORE IBE Device) for treatment of subjects with common iliac artery aneurysms (CIAA) or aorto-iliac aneurysms (AIA).
Gore Excluder bifurcated prosthesis.
Based on the statements above, the applicant maintained that the GORE IBE device is not substantially similar to other stent-grafts used to treat patients with AAAs. In the FY 2017 IPPS/LTCH PPS proposed rule, ( through 25059), we invited public comments on whether the GORE IBE device is substantially similar to existing technologies and whether the technology meets the newness criterion.
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