stent graft system News
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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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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 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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Endologix Receives CE Mark for ALTO Abdominal Stent Graft System
Transforming the treatment of aortic disorders, Endologix® Inc. (OTC: ELGXQ) (“Endologix” or the “Company”), today announced that it has received a CE Mark for the ALTOTM Abdominal Stent Graft System (ALTO). “We are very excited to receive a CE Mark for the ALTO system, that has been achieved through a strong partnership and collaboration with our European ...
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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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Endologix Launches ALTO™ Abdominal Stent Graft System in Europe
Furthering its mission to transform the treatment of aortic disorders, Endologix LLC today announced the first implant of its ALTO™ Abdominal Stent Graft, commencing the European commercial release of the recently CE Mark approved endograft. “We are pleased to expand the product launch to include Europe, making ALTO available to our physician partners and patients there as well as in ...
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Endologix Announces First Commercial Implant of ALTO Abdominal Stent Graft System Outside of United States
Furthering its mission to transform the treatment of aortic disorders, Endologix, Inc. (OTC: ELGXQ) (“Endologix” or the “Company”) today announced the first implant of its recently approved ALTO® endograft outside of the United States, completed by Andrew Holden, MD, and Andrew Hill, MD, of Auckland City Hospital, Auckland, New Zealand. “With the 7 mm infrarenal ...
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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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Second Heart Assist to Present Clinical Data at American Society for Artificial Internal Organs 66th Annual Conference
Salt Lake City, UT (April 30th, 2020) – Following blind peer review, Second Heart Assist’s clinical data presentation has been selected for oral presentation at the American Society of Artificial Organs (ASAIO) 66th annual conference, scheduled to be held entirely virtual by video June 10th-13th, 2020. The Second Heart Assist abstract will be published in the ASAIO Journal and will ...
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Second Heart Assist to Unveil Updated Wireless Power Design at ASAIO Annual Meeting
Salt Lake City, Utah, May 7th, 2020 – Second Heart Assist, the innovative developers of the world’s first percutaneous placed true aortic stent based circulatory assist pumps, are delighted to announce that they will provide a brief update on their breakthrough wireless powered chronic implant circulatory assist device, at the upcoming ASAIO tele-conference June 10-13, 2020. The ...
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