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Thoraflex™ Hybrid

Thoraflex™ Hybrid

Thoraflex™ Hybrid

Product catalog summary
Overview: The document discusses the Thoraflex™ Hybrid device, a branched Frozen Elephant Trunk Device available in Plexus and Ante-Flo™ configurations. It is designed to facilitate individual arch vessel reconstruction and the Island Technique, offering a one-stage operation for patients.
Specifications: The device features a compact design for better control, smaller distal stents (24 and 26mm) to treat a larger patient population, and a flexible shaft for easier shaping and trackability. It includes a rapid release sheath splitter clip mechanism for enhanced deployment performance.
Benefits: The Thoraflex™ Hybrid allows for earlier patient re-warming, reduced myocardial and lower body ischaemia, and shorter operating times. It supports a choice of surgical techniques, widening the treatable patient population.
Design Features: The Plexus and Ante-Flo™ designs enable individual arch vessel reconstruction or the Island Technique. The Gelweave™ Siena Collar ensures easier and safer anastomosis, reducing haemodynamic traction. Radiopaque markers simplify secondary procedures.
Ordering Information: The document provides detailed product ordering information for both Plexus and Ante-Flo™ configurations, including catalogue numbers, graft IDs, stent graft lengths, and diameters.
Clinical Outcomes: The implantation of the Thoraflex™ Hybrid device has resulted in excellent outcomes and beneficial aortic remodeling during follow-up, as supported by various clinical studies and reports.
References: The document cites several studies and reports that provide evidence of the device's effectiveness and innovative design.
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Catalog excerpts

Thoraflex™ Hybrid-2

The ONLY branched Frozen Elephant Trunk Device with Plexus and Ante-FloTM configurations Thoraflex™ Hybrid Plexus facilitates individual arch vessel reconstruction 1 Delivery system designed for intuitive and accurate deployment 2,3 1 Thoraflex™ Hybrid Ante-Flo™ configuration facilitates the Island Technique 2 Earlier re-warming, reduced myocardial ischaemia, lower body ischaemia and operating times 1,3,4 One-stage operation for the pati

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Thoraflex™ Hybrid-3

Plexus and Ante-Flo designs enable a choice of surgical techniques and widen the treatable patient population 2 TM Compact design aids delivery system control 3 More conformable flexible shaft allowing easier shaping to suit patient anatomy and system trackability 2 More intuitive rapid release sheath splitter clip mechanism designed for enhanced deployment performance 2 Smaller 24 and 26mm distal stents enable a larger patient population to be treated 2

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Thoraflex™ Hybrid-4

Implantation of the Thoraflex Hybrid device resulted in excellent outcomes and beneficial aortic remodelling during follow-up. 5 Thoraflex Hybrid used for the Frozen Elephant Trunk technique allows earlier patient re-warming, reduces myocardial ischaemia, lower body ischaemia and operating times. 1,3,4 Catalogue Number Explanation THP ThoraflexTM Hybrid Plexus Designation Proximal graft ID (mm) Distal stent graft OD (mm) Note: (i) Refer to IFU for full technical product details. (ii) Approximately 20mm between radiopaque markers. 3 Stent graft length (mm

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Thoraflex™ Hybrid-5

Choice of Plexus and Ante-FloTM designs for individual arch vessel reconstruction or the Island Technique 1,2 GelweaveTM Siena Collar ensures easier and safer anastomosis of the prosthesis to the aorta reducing the haemodynamic traction on the anastomosis 3 New smaller 24 and 26mm stent options Radiopaque markers simplify secondary procedures if needed 2 Multiple independent ring stent design allows excellent anatomical conformability 6 4

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Thoraflex™ Hybrid-6

Plexus Product Ordering Information MAIN GRAFT ID (mm) D1 ARCH BRANCH DIAMETERS ID (mm) Nominal length 100 / 150mm * Note: drawing not to scale

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Thoraflex™ Hybrid-7

Ante-Flo Product Ordering Information TM NOMINAL STENT LENGTH (mm) * * Nominal stent length quoted. Stent graft length may have some slight tolerance variance and can vary based on individual patient anatomy eg. tortuosity. Nominal length 100 / 150mm* Note: drawing not to scale

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Thoraflex™ Hybrid-8

References 1. Di Marco L et al. The Thoraflex™ Hybrid frozen elephant trunk device: the Bologna experience. J Vasc Endovasc Surg, 2014; 21(3), 117-23. 2. Clinical evaluation report for Thoraflex™ Hybrid device design dossier 019, Issue 4, Feb 2016. 3. Ruggieri VG et al. Multibranched hybrid device for frozen elephant trunk: what does it change? J Thoracic & Cardiovasc Surg, July 2015; 15(1), 253-255. 4. Maselli D et al. Frozen elephant trunk with Thoraflex™ Hybrid prosthesis: early results of the prospective THORA-FET registry. AATS Aortic Symposium, May 2016, NY, USA. 5. Shrestha M et al. Total...

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