Aortic System Articles & Analysis
17 news found
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 ...
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 ...
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 ...
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 ...
BioStable Science & Engineering, Inc., (“BioStable”) announced today the company has received CE Mark approval for the HAART 200 Aortic Annuloplasty Device for use during bicuspid aortic valve repair. With CE Mark approval of both the HAART 300 and HAART 200 Aortic Annuloplasty Devices, BioStable will be able to offer surgeons within the European Union a comprehensive portfolio of ...
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 ...
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 ...
NEWS PROVIDED BY Second Heart Assist, Inc. June 22nd, 2020 7:00am ET Salt Lake City, Utah, June 22nd, 2020 /PRDistribution/ — Second Heart Assist Inc., inventors of the first, true, aortic stent-based circulatory assist pump intended primarily for use in heart failure patients, announces the successful completion of a series of long-duration preclinical studies in pulsatile mock loop and ...
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 ...
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 ...
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 ...
Centerline Biomedical, Inc., a spinout company from Cleveland Clinic, announced the successful first human clinical use of its groundbreaking IOPS™ technology. IOPS, the Intra-Operative Positioning System, provides doctors performing minimally-invasive vascular repairs with an intuitive, interactive color 3D display. Used in conjunction with standard 2D grayscale X-ray fluoroscopy ...
Colibri Heart Valve LLC, a privately held emerging medical device company, today announced that results from the company’s international, single-arm, open-label early feasibility study (EFS) of the Colibri transcatheter aortic valve implantation (TAVI) system will be presented at the upcoming Transcatheter Cardiovascular Therapeutics (TCT) annual meeting taking place September 21-25, 2018 ...
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 ...
Colibri Heart Valve LLC, a privately held emerging medical device company, today announced that the Colibri transcatheter aortic valve implantation (TAVI) System has been used on an additional four patients in the ongoing international, single-arm, open-label early feasibility study (EFS). Initial post-implantation results from these patients, who received a 24mm valve, show favorable low aortic ...
Colibri Heart Valve LLC, a privately held emerging medical device company, today announced that the first two patients have been successfully enrolled in a clinical early feasibility study (EFS) of the company’s disruptive second-generation ready-for-use balloon-expandable transcatheter aortic valve implantation (TAVI) system. As with Colibri’s earlier generation system, this TAVI ...
Colibri Heart Valve LLC, a privately held emerging medical device company, has received an Issue Notification from the U.S. Patent and Trademark Office regarding the forthcoming granting of U.S. Patent No. 9,125,739 (the “’739 Patent”) titled, “Percutaneous Replacement Heart Valve and a Delivery and Implantation System.” This will be Colibri’s 12th ...