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Product Guide: Guidewires
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The following is our Cardiology Today Product Guide. Cardiology Today offered ICD manufacturers and marketers the opportunity to be listed here in our 2011 Guide. However, appearance does not imply endorsement by the chief medical editor or publisher of Cardiology Today. All of the information was supplied by the manufacturers; please contact them for more information. The editors regret any omissions.
Endurant AAA Stent Graft System
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The Endurant AAA Stent Graft System, manufactured by Medtronic, was approved in July 2008 for use in Europe for the endovascular treatment of infrarenal abdominal aortic of aortic-iliac aneurysms. It has been approved by the FDA as of December 2010. Based on data from a US study, the device is safe and effective for the treatment of abdominal aortic aneurysms. The system is a modular stent graft made of a specially woven fabric tube composed of multifilament polyester fabric sewn onto a flexible wire frame. It has a broader indication than previous stent grafts, allowing more patients to receive treatment for endovascular aneurysm repair. The system contains short, elastic, electropolished nitinol stents that conform to patient anatomies, including patients with tight or tortuous iliac arteries. It also contains active suprarenal fixation, a 3-cm overlap zone, and platinum-iridium and gold markers.
Talent Thoracic Stent Graft
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The Talent Thoracic Stent Graft with the Captivia Delivery System, manufactured by Medtronic, was approved by the FDA in October. It is specifically indicated for the endovascular repair of fusiform aneurysms and saccular aneurysms/penetrating ulcers of the descending thoracic aorta in patients having appropriate anatomy. The stent graft is made of a woven polyester tube (graft) supported by a nitinol metal stent. The device is available in longer lengths (up to 215 mm) than previous stent grafts, which helps doctors to treat patients who have longer aneurysms. The device was shown to be safe and effective as an alternative to open surgery in patients with thoracic aortic aneurysms. The Captivia Delivery System, used to deliver the device to the target location, has a tip capture mechanism that allows controlled deployment and precise placement of the graft; it also has hydrophilic coating that eases insertion.
Aorfix Endovascular Stent Graft
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The Aorfix Endovascular Stent Graft, manufactured by Lombard Medical Technologies, is a two-part modular implant that comprises a bifurcated main body section and a straight contralateral limb section. It is approved for use in Europe. As of December, the company has submitted the fifth of six premarket approval modules to the FDA. The final module, including clinical data, is expected to be filed in the first half of 2011. Aorfix is indicated for the endovascular treatment of infrarenal abdominal aortic, iliac and abdominal aortoiliac aneurysms. Results from multicenter study in Europe (the Arbiter II study) suggested that the device was safe and effective. The Aorfix contains a fish-mouth (used for neck positioning), eight fixation hooks, electropolished nitinol rings to adapt to highly angulated necks and radiopaque markers used for positioning. The delivery system allows controlled, step-by-step graft deployment in angles up to 90 degrees.
– Compiled by Emily Schafer; Photo credits: all photos courtesy of the manufacturers.