Aortic Disease Articles & Analysis
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News - Zero Contrast EVAR Round Table
This is a round table discussion about CO2 during EVAR and complex EVAR in the framework of our Annual Meeting of Angiodroid in Bologna, Italy. In this round table discussion, 5 European experts present current evidence and their experience about the use of CO2 in the treatment of aortic diseases . Moreover, the panellists discuss all important benefits and drawbacks of the technique 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 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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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 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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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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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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JenaValve Technology Closes $50 Million Financing
JenaValve Technology, Inc., developer and manufacturer of the JenaValve Pericardial Transcatheter Aortic Valve Replacement (TAVR) System for the treatment of aortic valve disease, announces that it has raised $50 million in an equity financing led by Bain Capital Life Sciences. Additional participants in the financing included existing investors Andera Partners, Gimv, Legend Capital, NeoMed ...
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JenaValve Announces Strategic Investment and Licensing Agreement with Peijia Medical Limited
JenaValve Technology, Inc. (“JenaValve” or the “Company”), developer and manufacturer of differentiated transcatheter aortic valve replacement (TAVR) systems, today announced a strategic investment and exclusive technology licensing agreement with Peijia Medical Limited (HKEX: 9996) in China. Under the terms of the agreement, Peijia has made a cash and equity investment in ...
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JenaValve Technology Welcomes Jane Metcalf as Vice President, Regulatory Affairs and Quality
JenaValve Technology, Inc., developer and manufacturer of differentiated pericardial transcatheter aortic valve replacement (TAVR) systems for the treatment of aortic valve disease, announces the appointment of Jane Metcalf toVice President, Regulatory Affairs and Quality, effective immediately. Ms. Metcalf comes to JenaValve with over 30 years of experience in themedical device industry ...
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JenaValve Technology Receives CE Mark for its Trilogy TAVI System for the Treatment of Aortic Regurgitation and Aortic Stenosis
JenaValve Technology, Inc., developer, and manufacturer of differentiated transcatheter aortic valve implantation (TAVI) systems (also referred to as TAVR, or transcatheter aortic valve replacement) for the treatment of aortic valve disease, today announced that it has received CE Mark for its TrilogyTM Heart Valve System for the treatment of both aortic regurgitation (AR), also known as aortic ...
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Centerline Biomedical Kicks Off First Clinical Study of Intra-Operative Positioning System Technology
Centerline Biomedical, Inc. (Centerline) announced Tuesday the completion of the first surgical case in its MOTION clinical study of its innovative Intra-Operative Positioning System (IOPS™) surgical navigation platform. The FDA-cleared technology is already being deployed in a controlled launch at Cleveland Clinic and other leading institutions in the United States. The MOTION study will ...
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JenaValve Receives IDE Approval to Initiate The ALIGN-AR Pivotal PMA Trial
JenaValve Technology, Inc., developer, and manufacturer of differentiated transcatheter aortic valve replacement (TAVR) systems, today announced FDA approval for the company to initiate its Investigational Device Exemption (IDE) PMA clinical trial for the Trilogy™ Heart Valve System for severe symptomatic, high-surgical risk aortic regurgitation. Aortic regurgitation (AR) is a condition ...
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JenaValve Announces First European Commercial Implants with the Trilogy™ Heart Valve System
JenaValve Technology, Inc., developer and manufacturer of differentiated transcatheter aortic valve replacement (TAVR) systems, today announced the first commercial implants with the Trilogy Heart Valve System in Europe. The procedures, which included treatment of both aortic regurgitation1 (AR) and aortic stenosis1 (AS), took place in multiple centers in Germany, marks the official start of the ...
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Anteris reports successful interim results for the first-in-human trial for DurAVR
Anteris Technologies Ltd (ASX: AVR) reports the first-in-human DurAVR™ THV study met or exceeded its interim study objectives. At the 30-day follow up point, the first five patients of the planned 10-patient study showed: All five subjects continued to do well with no reported adverse events (no death, stroke, myocardial infarction, reintervention). An average 86% improvement in mean ...
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