CLINICAL STUDY

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

Aorta Arch Solutions

D'Onofrio, A. Vascular News 2020

"Augusto D’Onofrio, Giorgia Cibin, and Michele Antonello outline the features and benefits of the JOTEC E-vita OPEN NEO and the NEXUS Aortic Arch Stent Graft System for the treatment of aortic arch pathologies."

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."

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."

Publications

"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 Arch Graft 

Lindsay, T. Linc Conference 2017.

"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 Off-The-Shelf Single Branch Device

Lachat, M. Veith Symposium 2019.

Case Studies

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

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

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.

Symptomatic Aortic Arch Contained Rupture
Scientific Publication Studies

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.