CLINICAL STUDY
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TRIOMPHE US IDE STUDY

Prospective, non-randomized, multi-center clinical investigation of the NEXUS™ Aortic Arch Stent Graft System (NEXUS™) for the treatment of thoracic aortic lesions involving the aortic arch with a proximal landing zone, native or previously implanted surgical graft, in the ascending aorta and with a brachiocephalic trunk native landing zone

Publications
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NEXUS Arch - A Multicenter Study Evaluating the Initial Experience

David MD; Elbaz-Greener, Gabby MD; Mangialardi, Nicola MD; Lindsay, Thomas MD; D’Onofrio, Augusto MD; Schelzig, Hubert MD; Chaykovska, Lyubov MD; Hill, Andrew MD; Holden, Andrew MD; Antonello, Michele MD; Tan, Kong T. MD; Orrico, Matteo MD; Ronchey, Sonia MD; Marmur, Yaniv BSc; Pecoraro, Felice MD; Lachat, Mario MD

"The NEXUS™ Aortic Arch Stent Graft System, a novel single branch, two stent graft system used for endovascular aortic arch repair that requires landing in the ascending aorta, demonstrates a high success rate with excellent one year safety and performance."

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Endovascular treatment of Aortic Arch Aneurism With A Single-Branched Double-Stage Stent Graft

Augusto D’Onofrio, MD, PhD, Michele Antonello, MD, PhD, Mario Lachat, MD, David Planer, MD, Andrea Manfrin, BSc, Andrea Bagno, BSc, David Pakeliani, MD, Franco Grego, MD, and Gino Gerosa, MD, Padova, Italy; Zurich, Switzerland; and Jerusalem, Israel

"Endovascular stent grafting of the aortic arch is a new promising emerging technology that allows the exclusion of aortic arch aneurisms through a micro-invasive procedure."

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Endovascular exclusion of the entire aortic arch with branched stent-grafts after surgery for acute type A aortic dissection

D’Onofrio et all – JTCVS Techniques 2020

This preliminary experience shows that ASG after surgery for AAD is feasible and provides encouraging clinical and anatomic early results.

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First Experience With the New NEXUS Stent Graft for the Arch

Mangialardi, N. Journal of Vascular Surgery 2015

"We believe that this graft will play a large role in the treatment of arch pathologies."

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Early Results of Arch Disease Treated with NEXUS Arch Endograft

Lindsay, T. Journal of Vascular Surgery 2017

"Our early experience with the NEXUS™ arch graft has been successful in treating challenging arch aneurysmal disease without stroke or mortality in a high-risk population."

presentations

"Effective minimally invasive option for aortic pathology involving the aortic arch • Approved Off-the-Shelf Solution (Feb. 2019) • Promising mid term results • Low procedural time results in procedural predictability"

Update on the NEXUS(TM) Off-The-Shelf Single Branch Device

Lachat, M. Veith Symposium 2019.

"Novel modular design with minimal arch manipulation • Arch debranching is still a major procedure • Favorable early results with no mortality, spinal cord ischemia or strokes • Applicable to arch aneurysms and type A dissections with ascending aortic grafts in place that require arch and descending aortic coverage"

Early Canadian Experience with the NEXUS(TM) Arch Graft

Lindsay, T. Linc Conference 2017.

Case Studies
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NEXUS AORTIC ARCH STENT GRAFT SYSTEM AND THE STABILISE TECHNIQUE TO SUCCESSFULLY TREAT A RESIDUAL TYPE A DISSECTION WITH ANEURYSMAL DEGENERATION

Hôpital Européen Georges-Pompidou
Paris, France

Post-operative course was uneventful, and the patient could be discharged at day 4 after 2 days of CSF drainage surveillance in the ICU. Pre-discharge control computed tomography confirmed optimal positioning of NEXUS™ in relation to a kink in the proximal ascending aorta surgical prosthesis, exclusion of proximal entry tear and a satisfying result of the STABILISE technique.

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MULTIDISCIPLINARY STAGED ENDOVASCULAR REPAIR OF THE AORTIC ARCH WITH NEXUS™

Interventional Radiology & Cardiovascular Department,
Aretaeio Hospital
Nicosia, Cyprus

The patient was discharged 1 day after the endovascular procedure. The discharge computed tomography angiography confirmed the absence of endoleaks proximally with an expected retrograde endoleak Type 1B which will be resolved at Stage 3.

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DURABILITY OF A CHALLENGING ENDOVASCULAR REPAIR OF THE AORTIC ARCH

Hirslanden Klinik
Zurich, Switzerland

The 21-month follow-up computed tomography angiography illustrated the integrity and stable position of NEXUS™ as well as complete exclusion of the aneurysm.

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FIRST EXPERIENCE WITH SENTINEL IN HIGH STROKE RISK PATIENT WITH AORTIC ARCH ANEURYSM

Hospital Universitario Puerta de Hierro Majadahonda
Madrid, Spain

Postoperative cerebral imaging didn’t reveal any sign of stroke, hemorrhage or respective micro bleeds, but slight signs of amyloidosis. Some days later, the patient was discharged home.

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CHRONIC DISSECTION PATIENT RECEIVES GROUNDBREAKING MINIMALLY INVASIVE TREATMENT IN TRIOMPHE CLINICAL STUDY

The Christ Hospital
Cardiothoracic Surgery Division
Cincinnati, Ohio

Six month follow-up CT shows a stable position of NEXUS™ and no endoleak identified.

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Symptomatic Aortic Arch Contained Rupture

Royal Brompton Hospital
London, UK

Due to the minimally invasive nature of the procedure, the patient was able to leave her bed very quickly and was discharged within a few days, with her recovery time reduced from several weeks.

Scientific Publication Summaries

Enrique M. San Norberto*, Noelia Cenizo, Cintia M. Flota & Carlos Vaquero. Rec Interv. Cardiol. 2020

Endovascular repair of the aortic arch with the NEXUS™ Stent Graft System

Endovascular repair of the aortic arch with the NEXUS™ Stent Graft System

A 75-year-old male patient underwent emergency surgery for acute type A aortic dissection repair.

Cibin et al. Ann Thorac Surg 2020

BAILOUT IMPLANTATION OF A NEW SINGLE-BRANCHED STENT GRAFT FOR THE AORTIC ARCH

BAILOUT IMPLANTATION OF A NEW SINGLE-BRANCHED STENT GRAFT FOR THE AORTIC ARCH

74-year-old male, COPD, previous MI, right nephrectomy (Ca), Diabetes Mellitus, Dyslipidemia, Button Bentall + Hemi Arch for Acute Type A Dissection.

Cibin et al. Ann Thorac Surg 2020

Bailout Implantation of a New Single-Branch Stent Graft for the Aortic Arch - The Annals of Thoracic Surgery

Bailout Implantation of a New Single-Branch Stent Graft for the Aortic Arch - The Annals of Thoracic Surgery

This case shows that urgent endovascular treatment of the aortic arch with an off-the-shelf single-branch bimodular aortic arch stent graft is feasible and can be performed with good early outcomes.

CAUTION: Investigational Device – Limited by United States law to investigational use. Endospan devices bear the CE marking of conformity.