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Ovation ALTO 腹主动脉支架移植物治疗腹主动脉瘤的概况:安全性和疗效概述。

Profile of the Ovation ALTO abdominal stent graft for the treatment of abdominal aortic aneurysms: overview of its safety and efficacy.

机构信息

East and North Hertfordshire Nhs Trust, Department of Radiology, Stevenage, UK.

East and North Hertfordshire Nhs Trust, Department of Vascular Surgery, Stevenage, UK.

出版信息

Expert Rev Med Devices. 2021 Dec;18(12):1145-1153. doi: 10.1080/17434440.2021.2013804. Epub 2021 Dec 14.

Abstract

INTRODUCTION

The Ovation ALTO is the next generation aortic stent graft from Endologix for the treatment of infra-renal abdominal aortic aneurysms. The device uses polymer-injected rings to create a proximal seal at the aneurysm neck.

AREAS COVERED

Results from the first clinical study of the ALTO graft are analyzed and the potential benefits of the graft in minimizing post-treatment aneurysmal neck dilation discussed. The implications of the ALTO's Instructions-For-Use (IFU) and low-profile delivery system are also reviewed.

EXPERT OPINION

The re-positioning of the sealing rings higher on the graft and an integrated compliant balloon are the most significant improvements on the Ovation iX, facilitating accurate placement of the proximal sealing ring and prompt balloon dilation of the polymer rings. The expansion the IFU to include neck lengths of ≥7 mm will mean more patients are eligible for infra-renal EVAR within IFU with the ALTO device. The published data on the device to date is limited. With over 1000 implants worldwide we would hope for more published data to become available. If this demonstrates similar mid-term results to that seen with the Ovation iX in arguably more hostile neck anatomy, then the Ovation ALTO is likely to be more widely used.

摘要

简介

Ovation ALTO 是 Endologix 公司研发的新一代腹主动脉瘤覆膜支架,用于治疗肾下型腹主动脉瘤。该器械采用聚合物注入环在瘤颈处形成近端密封。

涵盖领域

分析了 ALTO 移植物首次临床研究的结果,并讨论了该移植物在最小化治疗后瘤颈扩张方面的潜在优势。还回顾了 ALTO 的使用说明和低轮廓输送系统的影响。

专家意见

密封环在移植物上的重新定位以及集成顺应性球囊是对 Ovation iX 的最重要改进,有助于近端密封环的准确定位和聚合物环的迅速球囊扩张。将使用说明扩展到包括≥7mm 的颈部长度,将意味着更多符合使用说明的患者有资格接受肾下型 EVAR 治疗。迄今为止,该器械的已发表数据有限。在全球范围内已经有超过 1000 例植入,我们希望有更多的已发表数据可用。如果该数据显示与 Ovation iX 类似的中期结果,且在更具挑战性的颈部解剖中也是如此,那么 Ovation ALTO 可能会得到更广泛的应用。

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