Aortic Root Replacement Articles & Analysis
19 news found
iRhythm Technologies has presented new data on its Zio wearable cardiac monitoring device at the American College of Cardiology (ACC) 71st Annual Scientific Session & Expo, building the clinical case for its devices. One study used Zio AT for monitoring patients who were taken to hospital after fainting. By using the device to monitor patients after discharge, the physicians reduced ...
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 ...
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 ...
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 ...
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 five patients were successful and without any ...
Anteris Technologies Ltd (ASX: AVR) (Anteris or the Company) announces its submission at this year’s Transcatheter Cardiovascular Therapeutics (TCT) conference at Orlando, Florida, United States was accepted into the innovation session. The TCT conference, running from November 4 to 6, is the largest and most prestigious Interventional cardiology meeting held each year and will return to ...
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 ...
The implant was performed at Hannover Medical School. Paris, July 26, 2021 – 6:00 pm CEST CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, today announces the first implant of its Aeson® bioprosthetic artificial ...
ByCarmat
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 ...
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 ...
BioTrace Medical, Inc., the leader in innovative temporary pacing technology, today announced the company’s key activities at the 31st annual Transcatheter Cardiovascular Therapeutics (TCT) conference, which will take place September 25-29 in San Francisco. The company’s Tempo Temporary Pacing Lead will be featured in a breakfast symposium titled “Keeping the Rhythm with the ...
BioStable Science & Engineering, Inc., a medical technology company focused on products for aortic valve repair for the treatment of aortic insufficiency, today announced that over 500 patients worldwide have now been treated using the HAART Aortic Annuloplasty Device. “Many cardiothoracic surgeons recognize that the young aortic insufficiency patient population cannot be treated with ...
The company’s Tempo® Temporary Pacing Lead will be featured in a New Technology Forum discussion titled “Improved Temporary Transvenous Pacers: The BioTrace Tempo Lead,” presented by Steven Yakubov, M.D., System Chief, Advanced Structural Heart Disease at Riverside Methodist Hospital/OhioHealth. The discussion will highlight the performance and benefits of the Tempo Lead ...
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 ...
BioTrace Medical, Inc., the leader in innovative temporary pacing technology, today announced positive safety and effectiveness data from a physician-sponsored U.S. study of the company’s Tempo Temporary Pacing Lead. Results from a multi-center retrospective analysis of 224 U.S. interventional cardiac procedures, including transcatheter aortic valve replacement (TAVR), confirm the Tempo ...
BioTrace Medical, Inc., today announced the company’s key activities at the Transcatheter Cardiovascular Therapeutics (TCT) 2017 meeting, which will take place October 29 - November 2 at the Colorado Convention Center in Denver. The company’s Tempo Temporary Pacing Lead will be featured in a breakfast symposium titled: “The Tempo Temporary Pacing Lead: A New Standard of Care in ...