News | Endovascular Aortic Repair | November 11, 2019

Nexus Arch Branch Stent Graft System Shows Positive Mid-term Results

The Endospan Ltd. Nexus aortic arch stent graft is a CE mark–approved, off-the-shelf system for endovascular treatment of pathologies extending or involving the aortic arch.  #VIVA19 #VIVA2019

The Endospan Ltd. Nexus aortic arch stent graft is a CE mark–approved, off-the-shelf system for endovascular treatment of pathologies extending or involving the aortic arch. 

November 7, 2019 — The Endospan Ltd. Nexus aortic arch stent graft is a CE mark–approved, off-the-shelf system for endovascular treatment of pathologies extending or involving the aortic arch. Two-year results from a prospective multicenter premarket study including 25 patients (mean age, 73 years) treated with Nexus were presented at the 2019 Vascular Interventional Advances (VIVA) annual meeting.

Mid-term results at a mean 25-month follow-up are stable without any material failure or stent graft issues, said presenter Daniel Clair, M.D., chair of the Department of Surgery at Palmetto Health-USC Medical Group and senior medical director for Surgical Services at Prisma Health–Midlands. However, he said more experience and longer follow-up are necessary to confirm these promising mid-term results.

Nexus is a modular stent graft introduced via a 20 French delivery system with double flushing ports, which allows efficient de-airing. The main module is deployed over an axillofemoral guidewire to extend from the brachiocephalic trunk to the descending aorta and is combined with a pre-curved ascending module that conforms to the ascending aorta.

All patients had aneurysm size >55 mm and were considered high risk for conventional open arch surgery by a multidisciplinary team. Indications for treatment were aneurysm (15 [60%] patients) or dissection (10 [40%] patients), including seven patients previously treated surgically for type A dissection. Thirteen (52%) patients had prior thoracic aortic surgery. Supra-aortic bypasses were performed prior to Nexus implantation.

Technical success was achieved for all intended Nexus introductions and deployments (100%). At 30 days, two (8%) patients died from cardiac causes and two (8%) patients showed nondisabling stroke, which resolved completely within 30 days. During a mean follow-up of 25 months, there was one additional procedure-related mortality from stroke, and one patient was converted to open surgery following retrograde type A dissection. During follow-up, aneurysm size decreased or remained stable in 96% of the patients, with no aneurysm-related deaths.

The Nexus system is the first European CE mark–approved branched stent graft for the aortic arch. Design features that assist in minimizing manipulations may explain the high technical success, low rate of neurologic complications, and durability, allowing safe endovascular repair.

Find information on all the VIVA 2019 Late-breaking Clinical Trials

Related Content

The first 3-D images have been created of an RNA molecule known as "Braveheart" for its role in transforming stem cells into heart cells. Credit: Image courtesy Los Alamos National Laboratory

The first 3-D images have been created of an RNA molecule known as "Braveheart" for its role in transforming stem cells into heart cells. Credit: Image courtesy Los Alamos National Laboratory

News | Cardiovascular Clinical Studies | January 20, 2020
January 20, 2020 — Scientists at Los Alamos and international partners have created the first 3-D images of a special
Top Cardiology New in 2019 From the European Society of Cardioloigy (ESC)
News | Cardiovascular Clinical Studies | December 23, 2019
Environmental and lifestyle issues were popular this year, with pick up from both...
News | Cardiovascular Clinical Studies | November 26, 2019
November 26, 2019 — The University of Connecticut (UConn) Department of Kinesiology and Hartford Healthcare have sele
FDA Issues Final Guidance on Live Case Presentations During IDE Clinical Trials
News | Cardiovascular Clinical Studies | July 10, 2019
The U.S. Food and Drug Administration (FDA) issued the final guidance “Live Case Presentations During Investigational...
Veradigm Partners With American College of Cardiology on Next-generation Research Registries
News | Cardiovascular Clinical Studies | July 03, 2019
The American College of Cardiology (ACC) has partnered with Veradigm, an Allscripts business unit, to power the next...
New FDA Proposed Rule Alters Informed Consent for Clinical Studies
News | Cardiovascular Clinical Studies | November 19, 2018
The U.S. Food and Drug Administration (FDA) is proposing to add an exception to informed consent requirements for...
A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp
Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Cardiovascular Clinical Studies | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo
Lexington Begins HeartSentry Clinical Trial
News | Cardiovascular Clinical Studies | February 20, 2018
February 20, 2018 – Lexington Biosciences, Inc., a development-stage medical device company, announced the commenceme
Overlay Init