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Which Interventional Device Review: Aorfix, Lombard Medical
Features
The Aorfix is a modular infra-renal aortic endovascular device that appears quite unique in terms of the flexibility of the components. Although the manufacturers will of course hope that we will use this as our standard device for abdominal AAA this device is aimed particularly at those difficult cases with extremely tortuous proximal necks or kinked iliac vessels.
Design/construction
The stent-graft is comprised of nitinol hoops stitched in to the graft polyester, making for an unusually compliant device. Paired barbs at the proximal margin help to secure the top end together with a ‘fish-mouth’ shape to the (largest) top hoop which adds radial force to this proximal fixation. The introduction system includes a pair of longitudinal rods within the endograft in order to support the top end during the deployment process. This ensures an extra degree of control prior to final release and fixation of the proximal margin.
Deployment
This is by no means intuitive. The introduction system is somewhat over-engineered and there have been complaints that the deployment procedure is too complicated. Two pairs of hands may be required to support the sheathed section and operate the deployment handle. A proctor with a thorough understanding of each component of the device and the introduction system is particularly important during initial trials!
Results so far
Our initial experience of this device was rather discouraging, but perseverance has resulted in success in a small number of rather difficult cases. We are now actively pursuing the use of the Aorfix for those cases with very tortuous aorto-iliac segments in which we would previously have been more hesitant to use an endograft.
Comparisons
Certainly this device is not as easy to use as many of the more established stent-grafts. There are no significant differences in terms of cost. There is as yet little in the way of trial or registry data for Aorfix that could allow comparison of the medium and longer term clinical outcomes
Conclusion
The Aorfix device seems to be applicable to a niche application in EVAR. It is as yet too early to be sure that this somewhat novel device will stand the test of time.
Dr John Rose (Consultant Radiologist)
For images and full review, please visit radRounds Partner Site: WhichInterventionalDevice
http://www.whichradiologydevice.com/
The Aorfix is a modular infra-renal aortic endovascular device that appears quite unique in terms of the flexibility of the components. Although the manufacturers will of course hope that we will use this as our standard device for abdominal AAA this device is aimed particularly at those difficult cases with extremely tortuous proximal necks or kinked iliac vessels.
Design/construction
The stent-graft is comprised of nitinol hoops stitched in to the graft polyester, making for an unusually compliant device. Paired barbs at the proximal margin help to secure the top end together with a ‘fish-mouth’ shape to the (largest) top hoop which adds radial force to this proximal fixation. The introduction system includes a pair of longitudinal rods within the endograft in order to support the top end during the deployment process. This ensures an extra degree of control prior to final release and fixation of the proximal margin.
Deployment
This is by no means intuitive. The introduction system is somewhat over-engineered and there have been complaints that the deployment procedure is too complicated. Two pairs of hands may be required to support the sheathed section and operate the deployment handle. A proctor with a thorough understanding of each component of the device and the introduction system is particularly important during initial trials!
Results so far
Our initial experience of this device was rather discouraging, but perseverance has resulted in success in a small number of rather difficult cases. We are now actively pursuing the use of the Aorfix for those cases with very tortuous aorto-iliac segments in which we would previously have been more hesitant to use an endograft.
Comparisons
Certainly this device is not as easy to use as many of the more established stent-grafts. There are no significant differences in terms of cost. There is as yet little in the way of trial or registry data for Aorfix that could allow comparison of the medium and longer term clinical outcomes
Conclusion
The Aorfix device seems to be applicable to a niche application in EVAR. It is as yet too early to be sure that this somewhat novel device will stand the test of time.
Dr John Rose (Consultant Radiologist)
For images and full review, please visit radRounds Partner Site: WhichInterventionalDevice
http://www.whichradiologydevice.com/
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