Thoracic on Captivia
Thoracic on Captivia
The Talent Thoracic Stent Graft has been used internationally to repair thoracic aneurysms in over 20,000 patients.
The long-term safety and effectiveness of this implant have not been established. All patients with endovascular aneurysm repair must undergo periodic imaging to evaluate the stent graft and aneurysm size. Significant aneurysm enlargement (>5 mm), the appearance of a new endoleak, or migration resulting in an inadequate seal zone should prompt further investigation and may indicate the need for additional intervention or surgical conversion.
Based on published data from all U.S. manufacturers; Lack of patency is commonly associated with events such as stent graft collapse, infolding, fractures, kinking, and twisting; Data on file. Medtronic Vascular, Santa Rosa, CA, 2009.
Data on file. Medtronic Vascular, Santa Rosa, CA, 2009. Circumferential compression test. Bench test results may not be indicative of clinical performance.
Medtronic Field Assurance Worldwide Complaints on CoilTrac, January, 2002 – April 15, 2008 inclusive.
The Talent Thoracic Stent Graft includes:
The Talent thoracic stent graft is pre-loaded into the Captivia delivery system. The loaded delivery system is inserted endoluminally via the femoral or iliac artery and tracked through the patient's vasculature to deliver the stent graft to the target site.
The Talent Thoracic Stent Graft is a modular device system that accommodates the use of multiple stent graft sections. Depending on the patient's anatomy, single or multiple stent grafts may be required to achieve sufficient coverage and exclude the target lesion.
The Talent thoracic stent graft is composed of a series of shaped, sinusoidal, self-expanding nitinol wire rings which act as springs that are stacked in a tubular arrangement to form a self-expanding nitinol structure. A full-length connecting bar connects the proximal and distal springs of the stent graft. A monofilament polyester woven graft covers the self-expanding nitinol structure. The graft material is sewn to the nitinol structure, which securely incorporates the springs into the graft.
The Captivia delivery system features a tip capture mechanism for controlled deployment and precise placement.1 The outer sheath features a hydrophilic coating to facilitate stent graft delivery.
Radiopaque markers, made out of platinum-iridium in the shape of a figure eight (known as Figur8), are sewn to the graft to help visualize and identify the following: the edge of the graft material; the location of the connecting bar; and the minimum overlap required when multiple stent grafts are used. A support spring surrounding the proximal edge of the graft material is also used in some configurations.
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Data on file, deployment accuracy test. Bench test data is not indicative of clinical performance. Medtronic Vascular; Santa Rosa, CA; 2009