Aortic System Articles & Analysis
22 news found
FDA approval for the Trilogy Heart Valve System.” “With the addition of the TrilogyTM, Peijia will have a more comprehensive product portfolio to better serve patients with aortic valve diseases in China,” said Dr. ...
Anteris reports successfully implanting five TAVR patients during the week of 14 November 2021 in a first-in-human (FIH) study to assess the DurAVR THV system for treating severe aortic stenosis. The study was carried out at the Tbilisi Heart and Vascular Clinic, Tbilisi, Georgia. The transcatheter aortic valve replacement procedures for all ...
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. ...
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 ...
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 ...
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 ...
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. ...
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 recent successful completion of these long-duration in vivo studies, utilizing the percutaneously delivered Second Heart Assist circulatory assist pump within a true aortic stent, demonstrates the desired durability needed to address an increasing patient population suffering from advanced heart ...
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 ...
Both of these devices have a firm fixation, true aortic stent that maintains positioning with security and also is able to maintain both aortic wall motion and blood flow pulsatility deemed essential for optimizing hemodynamics during long duration circulatory support. ...
The designation of NEXUSTM Aortic Arch Stent Graft System as a breakthrough device acknowledges the unmet need in this patient population and the potential for improvements over current standard treatments. ...
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. ...
IOPS, the Intra-Operative Positioning System, provides doctors performing minimally-invasive vascular repairs with an intuitive, interactive color 3D display. ...
(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 off-the-shelf endovascular stent graft system approved for the repair of both aneurysms and dissections in the aortic arch. ...
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 ...
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. ...
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 ...
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). ...
The company’s second-generation TAVI system includes enhancements to address a wider range of patient candidates including those with bicuspid aortic valves. ...