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Biomedical Devices: Overview
Published in Jack Wong, Raymond K. Y. Tong, Handbook of Medical Device Regulatory Affairs in Asia, 2018
One of the major vascular diseases, abdominal aortic aneurysms (AAA) is a localized swelling (ballooning) of the abdominal aorta, caused by the weakness of the aortic wall. Untreated condition is likely to cause rupture and associated death in one- third of patients. Although there are about 27 million people worldwide suffering from AAA, only 20% are detected [29]. Ultrasound screening for AAA can be adopted to improve the accuracy of the detection. Endovascular aneurysm repair (EVAR) is a minimally invasive procedure that is also used in the treatment of AAA. In an EVAR, a manufactured device known as a stent-graft is deployed under x-ray guidance inside the aneurysm to exclude it from the circulation (30). The principle is illustrated in Fig. 11.5.
Elements of Continuum Mechanics
Published in Clement Kleinstreuer, Biofluid Dynamics, 2016
Minimally invasive endovascular repair. In contrast to open aneurysm repair, a minimally invasive treatment, called endovascular aneurysm repair (EVAR), is performed remotely using a long thin tube, called a catheter. For aortic aneurysms, the surgeon makes a small incision in each upper thigh; then, guided by X-rays or other screens, passes the stent-graft (ePTFE or PET tube with an imbedded tubular metal mesh, compressed in the delivery device) through the vessel in the thigh to the aneurysm site. After it is correctly positioned in the abdominal aorta, the stent-graft is released and restores to its original shape. After balloon- or self-expansion of the stentgraft, the delivery catheter is withdrawn. The aneurysm cavity is excluded by the stent-graft and the blood pressure load is carried by the implant, preventing aneurysm rupture (Fig.5.4.4).
A systematic review of standardized methods for assessment of endograft sealing on computed tomography angiography post-endovascular aortic repair, and its influence on endograft-associated complications
Published in Expert Review of Medical Devices, 2019
Richte C.L. Schuurmann, Philippe M. De Rooy, Frederico Bastos Gonçalves, Cornelis G. Vos, Jean-Paul P.M. De Vries
Endovascular aneurysm repair (EVAR) has been widely adopted as a treatment for patients with abdominal or thoracic aortic aneurysms (AAA/TAA). Concern for secondary aneurysm sac rupture as a result of endoleak makes life-long surveillance mandatory[1]. Contrary to assessment of the pre-operative anatomy on computed tomography (CT) angiography (CTA) volumes, which is incorporated in international guidelines and manufacturers’ indications for use, standardized assessment of the endograft on postoperative CTA scans is underreported.
The Altura endograft system for endovascular aneurysm repair: presentation of its unique design with clinical implications
Published in Expert Review of Medical Devices, 2022
Efstratios Georgakarakos, Konstantinos Dimitriadis, Gioultzan Memet Efenti, Georgios I Karaolanis, Christos Argyriou, George S. Georgiadis
Endovascular Aneurysm Repair (EVAR) is considered the treatment of choice for abdominal aortic aneurysms (AAA), associated with low perioperative morbidity and mortality. The generalized application of EVAR has reduced mortality rates for both ruptured and unruptured cases by more than 50% during the past 10 years [1–3].