Aortic Arch Articles & Analysis
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FDA Grants NEXUS Aortic Arch Stent Graft System Breakthrough Designation
Endospan, a pioneer in off-the-shelf endovascular repair of aortic arch disease was recently granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the NEXUS™ Aortic Arch Stent Graft System. The FDA’s Breakthrough Device Designation Program is intended to provide timely access to medical devices that have the potential to provide a more effective ...
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Endospan Enrolls First Patient in the TRIOMPHE IDE Study
Endospan, a pioneer in off-the-shelf endovascular repair of aortic arch disease, announces the first implant of the NEXUS™ Aortic Arch Stent Graft System on a patient with a thoracic aortic aneurysm as part of the TRIOMPHE Study in Norfolk, Virginia, January 11, 2021. The TRIOMPHE Study is a multi-arm, multi-center, non-randomized, prospective, clinical study to evaluate the safety and ...
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Endospan elects Jeff Elkins as a director
Endospan, a pioneer in off-the-shelf endovascular repair of Aortic Arch Disease including aneurysms and dissections, today announced that it has elected Jeff Elkins to its board of directors. Elkins has been President and CEO of Veniti Inc. since July 2015. Previously, Elkins was COO and earlier CEO of Aptus Endosystems, acquired by Medtronic; and, founding COO of FlowMedica, acquired by ...
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Endospan receives CE mark for HORIZON EVAR system based on robust clinical and pivotal data to treat Abdominal Aortic Aneurysm (AAA)
Endospan, a pioneer in off-the-shelf EndoVascular Aortic Repair (EVAR), announced today that it has received CE marking for its HORIZON Stent Graft System to treat Abdominal Aortic Aneurysm (AAA). “HORIZON is a unique platform that can be used in a 14Fr single-sided approach, generally shortening and simplifying EVAR procedures,” said Kevin Mayberry, CEO. “HORIZON is supported ...
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Endospan Enters Into Strategic Distribution Agreement With CryoLife
Endospan, a pioneer in off-the-shelf endovascular repair of aortic arch disease, today announced it has entered into strategic distribution and credit facility agreements with CryoLife, Inc. (NYSE: CRY), a leading cardiac and vascular surgery company focused on aortic disease. Under the terms of the agreement, CryoLife will have exclusive European distribution rights to NEXUS™, the first ...
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Terumo Aortic Announces US FDA Approval for Thoraflex Hybrid
Terumo Aortic today announced that the US Food and Drug Administration (FDA) has granted approval of the Thoraflex Hybrid Frozen Elephant Trunk (FET) device for commercial sale in the United States for the treatment of patients with complex aortic arch disease. Thoraflex Hybrid is the first of its kind device used in Frozen Elephant Trunk (FET) repair in the United States and was granted ...
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