Vaislic, MFM book chapter, page proofs, 12.5.16

Introduction

Outcomes are now available out to 4 years for the prospective nonrandomized STRATO trial. Th is 10-center French study was undertaken between April 2010 and February 2011 in order to assess the effi cacy, safety, and performance of the Multilayer Flow Modulator (MFM) (Cardiatis, Isnes, Belgium) and its device delivery system in patients ineligible for surgical or endograft repair presenting with Crawford type II and III thoracoabdominal aneurysms (TAAA).1, 2 Th e MFM is an uncovered, self-expanding stent with high radial force and fl exibility constructed of braided fatigue- and corrosionresistant cobalt-alloy wire (Phynox). Th e device was designed to thrombose and stabilize the aneurysm sac while creating an organized laminar fl ow into covered branch vessels without the need for the extra steps involved in cannulation.3 Th e MFM received CE marking for peripheral artery aneurysms in 2009 and for aortic aneurysms in 2011. It was thought that the flow-diverting MFM technology could have numerous potential advantages for treating challenging TAAA — particularly type II and III TAAA that span the ostia of visceral and renal arteries — as an alternative to physician-modifi ed or commercially customized fenestrated and/or branched endografts. Th ose endovascular approaches have been associated with high costs, long manufacturing delays, extended learning curve, and outcomes including perioperative spinal cord ischemia (SCI), renal insufficiency, type I and III endoleak, and frequent need for reintervention.4-9

By contrast, the MFM is an off -the shelf device available in a wide range of sizes. While preoperative assessment of patient anatomy and pathology and evaluation of landing zones and device sizing are still important with the MFM, extensive measurements and calculations are not required regarding visceral side branch location, diameters, and angulation. Treatment with the MFM can also be less invasive, with vascular access limited to a single sheath in one femoral/brachial artery for introduction of an angiographic catheter and another sheath in the other femoral artery for introduction of the device, without the need for additional upperextremity access. Implantation of the MFM requires


 

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