Case Report of an Endovascular Repair of a Residual Type A Dissection Using a Not CE Not FDA-Approved Najuta Thoracic Stent Graft System

Abstract

This report describes an endovascular repair of a residual type A dissection using a medical device that is not marked by european conformity (CE) or Food and Drug Administration (FDA).The patient underwent ascending aortic surgery for acute type A dissection. The 2-year angio–computed tomography demonstrated patency of the residual false lumen with evolution into a 6 cm aneurysm, the extension of the dissection from the aortic arch to the aortic bifurcation with thrombosis of the right common iliac artery. There was no CE- or FDA-marked medical device indicated for this case or any other acceptable therapeutic alternative.We used the Najuta thoracic stent graft and successfully handled the pathology in a multiple-phase treatment.Technology is evolving with specific grafts for the ascending and fenestrated grafts for the aortic arch. In this single case the Najuta endograft, in spite of the periprocedural problems, was a valid therapeutic option.

Endovascular repair of ascending aorta pseudoaneurysm

“…Another reason to choose the left axillary artery was that the proximal abdominal cuff is designed with a short delivery sheath that cannot reach the ascending aorta from the femoral artery. This is the reason why several alternative vascular access, such as axillary, carotid and subclavian artery, or even the apex of left ventricle, has begun to be used during endovascular procedure on the ascending aorta (8)(9)(10)(11)(12). In our opinion, the approach we used facilitated the accuracy of the deployment allowing to avoid the multiple curvatures of the others, possibles, approaches and increasing the safety and the accuracy of the landing at the coronary ostia.…”

Alternative management of proximal aortic dissection: concept and application

“…In the USA, the first stentgraft for use in the ascending aorta is the modified COOK TX2 Thoracic Stent-graft without proximal bare metal (with a diameter up to 46 mm and a treatment length up to 90 mm), and the investigational short GORE Active Control device is used in the ongoing Ascend trial. Fenestrated, branched, bifurcate, and custom-made endografts may also play a role in the future of endovascular treatment of TAAD [50,51]. Additionally, strategies for graft delivery must be upgraded alongside the design of arch-specific stent-grafts.…”

Minimally Invasive Techniques for Total Aortic Arch Reconstruction

“…20 Excellent results with custom-made fenestrated devices have been reported. [21][22][23] The Japanese Najuta fenestrated thoracic stent graft (Kawasumi Laboratories, Tokyo, Japan) uses a combination of preformed stainless steel stents, externally attached PTFE, and curved delivery sheaths for total endovascular aortic arch reconstruction. In a study of the first-generation thoracic stent graft in more than 380 patients, technical success was achieved in 95.8% of patients, with a perioperative mortality rate of 1.6%, paraplegia rate of 0.8%, and CVA rate of 1.8%.…”