Endospan Receives FDA IDE Approval to Initiate a Pivotal Study of the NEXUS™ Aortic Arch Stent Graft System

Endospan , a pioneer in off-the-shelf endovascular repair of aortic arch disease received approval from FDA of an investigational device exemption, or IDE, to start the TRIOMPHE study on the NEXUS Aortic Arch Stent Graft System (hereinafter referred to as NEXUSTM).

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Monday, August 17, 2020
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FDA, Health, Cardiology, Medical devices, Anatomy, Angiology, Torso, Interventional radiology, Aorta, Stent, Investigational device exemption, Aortic arch, Vascular surgery, Vascular diseases, Thoracic aortic aneurysm, Aortic aneurysm
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United States, Europe, Middle East, Israel, NEW YORK
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ENDOSPAN
Summary
Key Points: 
  • Endospan , a pioneer in off-the-shelf endovascular repair of aortic arch disease received approval from FDA of an investigational device exemption, or IDE, to start the TRIOMPHE study on the NEXUS Aortic Arch Stent Graft System (hereinafter referred to as NEXUSTM).
  • The TRIOMPHE pivotal study will assess the NEXUSTM in some of the most challenging Aortic Arch Pathologies that we encounter.
  • Endospans NEXUSTM Aortic Arch Stent Graft System is the first endovascular off-the-shelf system with CE Mark to treat a greatly underserved group of patients diagnosed with a dilative lesion in, or near the aortic arch.
  • NEXUSTM Aortic Arch Stent Graft System is currently available for sale in Europe and is intended for investigational use only in the U.S.
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Endospan, a pioneer in off-the-shelf endovascular repair of aortic arch disease received approval from FDA of an investigational device exemption, or IDE, to start the TRIOMPHE study on the NEXUS™ Aortic Arch Stent Graft System (hereinafter referred to as NEXUSTM). Earlier this year, FDA granted NEXUSTM designation as a breakthrough device. This designation acknowledges the NEXUSTM may provide a more effective treatment for life-threatening or irreversibly debilitating diseases or conditions.

Minimally invasive techniques are standard-of-care for treating descending aortic disease and heart disease, but highly invasive, high-mortality open surgery is still being used in the difficult-to-treat aortic arch anatomy. The NEXUSTM is uniquely engineered to address this significant area of unmet clinical need. More than 120,000 patients suffer thoracic aortic arch disease every year in the USA and Europe, with only about 25% being diagnosed or treated. This global market opportunity is over $1.3 billion in a high average selling segment with no other off-the-shelf competition to the NEXUS™ technology.

The prospective and multi-arm pivotal IDE TRIOMPHE study will evaluate in up to 30 centers, the safety and effectiveness of the NEXUS™ for the endovascular treatment of thoracic aortic lesions involving the aortic arch including chronic dissections, aneurysms, penetrating aortic ulcers and intramural hematoma.

“The TRIOMPHE pivotal study will assess the NEXUSTM in some of the most challenging Aortic Arch Pathologies that we encounter. For the patient, there are limited options to treat these life threatening pathologies. The NEXUSTM device is designed to address most of those complexities through a minimally invasive approach with the potential to provide a safe and durable solution,” indicated the National principal co-investigator, Dr. Ross Milner, Professor of Surgery, Co-Director, Center for Aortic Diseases at the University of Chicago.

Brad Leshnower, Associate Professor of Surgery, Division of Cardiothoracic Surgery, Department of Surgery, Emory University School of Medicine, the National principal co-investigator stated, “There are a significant number of patients who are too high risk for open surgical treatment who are also at significant risk from their aortic arch disease. The NEXUSTM provides an innovative minimally invasive option, which provides cardiac surgeons, if proven safe and effective, the potential to save the lives of patients who would have previously had no other treatment options available.”

Kevin Mayberry CEO of Endospan added, “This is a significant milestone for Endospan in bringing the NEXUSTM towards US patients. We are very encouraged by the European clinical data and commercialization of NEXUSTM in Europe. Starting a pivotal study in the U.S. brings us one step closer to our goal of providing an endovascular approach to treat aortic arch disease pathologies."

About Endospan

Privately held Endospan, headquartered in Herzlia (Tel Aviv), Israel, is a pioneer in the endovascular repair of aortic arch disease including aneurysms and dissections. Endospan’s NEXUSTM Aortic Arch Stent Graft System is the first endovascular off-the-shelf system with CE Mark to treat a greatly underserved group of patients diagnosed with a dilative lesion in, or near the aortic arch. While minimally invasive endovascular repair has been the standard of care for Abdominal Aortic Aneurysm (AAA), Aortic Arch Disease patients with aneurysms or dissections have not been as fortunate and have had little choice but to undergo open-chest surgery with its invasiveness and risks, lengthy hospitalization periods, and prolonged recuperation. For additional information about Endospan, visit their website at www.endospan.com.

NEXUSTM Aortic Arch Stent Graft System is currently available for sale in Europe and is intended for investigational use only in the U.S.

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