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Aortic Heart Valve Articles & Analysis

31 news found

SafeHeal appoints medical device industry veteran Chris Richardson as Chief Executive Officer

SafeHeal appoints medical device industry veteran Chris Richardson as Chief Executive Officer

Most recently, he was President and CEO of Keystone Heart, a structural heart medical device company, and creator of the first Cerebral Embolic Protection device designed to provide complete coverage to all brain regions for patients undergoing cardiac procedures. Keystone Heart was acquired in 2018 by Venus Medtech, the leader in transcatheter ...

BySafeHeal


iRhythm builds case for wearable cardiac monitor with data in fainting, TAVR patients

iRhythm builds case for wearable cardiac monitor with data in fainting, TAVR patients

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 ...

ByZio by iRhythm Technologies, Inc.


Anteris reports successful interim results for the first-in-human trial for DurAVR

Anteris reports successful interim results for the first-in-human trial for DurAVR

“The excellent results observed so far are a function of the proprietary 3D single-piece leaflet design of DurAVR™ that mimics a native aortic valve. These numbers are even more remarkable considering this cohort had small annular anatomy. ...

ByAnteris Technologies Limited


JenaValve Announces Strategic Investment and Licensing Agreement with Peijia Medical Limited

JenaValve Announces Strategic Investment and Licensing Agreement with Peijia Medical Limited

I am pleased to say, that following IDE approval of the ALIGN-AR Trial in August 2021, patient enrollment remains on track as we diligently work to achieve our ultimate goal of receiving U.S. 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 ...

ByJenaValve Technology, Inc.


BIOMODEX and Montreal Heart Institute Team Up to Develop 3D Printed Pulsatile Heart Models

BIOMODEX and Montreal Heart Institute Team Up to Develop 3D Printed Pulsatile Heart Models

BIOMODEX®, the leader in biorealistic haptic simulators for physician training and rehearsals, and the Montreal Heart Institute (MHI), a world-renowned, ultra-specialized cardiology center, announced they are partnering to develop a new cardiovascular training solution to help cardiologists rehearse and train for complex valve-in-valve ...

ByBIOMODEX


CytoSorbents Appoints Daniel Wendt, MD, PhD, MHBA, FECTS as Vice President, Medical Affairs Cardiovascular

CytoSorbents Appoints Daniel Wendt, MD, PhD, MHBA, FECTS as Vice President, Medical Affairs Cardiovascular

Wendt serves as Co-director of the Thoracic and Cardiovascular Surgery Clinic, West German Heart and Vascular Center in Essen, Germany and is Professor of Cardiac Surgery at Essen University Medical School. ...

ByCytoSorbents Corporation


Five TAVR Patients Successfully Implanted with DurAVR Valve

Five TAVR Patients Successfully Implanted with DurAVR Valve

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 ...

ByAnteris Technologies Limited


DurAVR accepted into TCT innovation session

DurAVR accepted into TCT innovation session

About Anteris Technologies Ltd (ASX: AVR) Anteris Technologies Ltd is a structural heart company delivering clinically superior and durable solutions through better science and better design. Its focus is on developing next generation technologies that help healthcare professionals create life-changing outcomes for patients. The Anteris DurAVR™ aortic ...

ByAnteris Technologies Limited


JenaValve Announces First European Commercial Implants with the Trilogy™ Heart Valve System

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. ...

ByJenaValve Technology, Inc.


CytoSorbents Announces Availability of Preliminary Data Abstracts from Two Endocarditis Studies, including the REMOVE study, to be Presented at the EACTS Conference

CytoSorbents Announces Availability of Preliminary Data Abstracts from Two Endocarditis Studies, including the REMOVE study, to be Presented at the EACTS Conference

Phillip Chan, Chief Executive Officer of CytoSorbents, stated, “Today, infective endocarditis makes up a minor part of our overall usage and revenue in cardiac surgery and we believe that CytoSorb will continue to be used in selected infective endocarditis populations. For example, prosthetic heart valve endocarditis is associated with very high mortality ...

ByCytoSorbents Corporation


JenaValve Receives IDE Approval to Initiate The ALIGN-AR Pivotal PMA Trial

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 ...

ByJenaValve Technology, Inc.


First human implant of the Aeson artificial heart in Germany

First human implant of the Aeson artificial heart in Germany

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 Receives CE Mark for its Trilogy TAVI System for the Treatment of Aortic Regurgitation and Aortic Stenosis

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 ...

ByJenaValve Technology, Inc.


BioStable Science & Engineering Announces CE Mark Approval for the HAART 200 Aortic Annuloplasty Device & Surpasses 1,000 Patients Treated Worldwide with the HAART Devices

BioStable Science & Engineering Announces CE Mark Approval for the HAART 200 Aortic Annuloplasty Device & Surpasses 1,000 Patients Treated Worldwide with the HAART Devices

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 aortic valve repair solutions that address all forms of aortic valve insufficiency. In addition, BioStable announced that over ...

ByBioStable Science & Engineering, Inc.


JenaValve Technology Welcomes Jane Metcalf as Vice President, Regulatory Affairs and Quality

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. ...

ByJenaValve Technology, Inc.


JenaValve Technology Closes $50 Million Financing

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 ...

ByJenaValve Technology, Inc.


BioTrace Medical Announces Key Events Featuring Tempo Temporary Pacing Lead at TCT 2019

BioTrace Medical Announces Key Events Featuring Tempo Temporary Pacing Lead at TCT 2019

The company’s Tempo Temporary Pacing Lead will be featured in a breakfast symposium titled “Keeping the Rhythm with the Tempo Lead: Safety, Stability, and Ambulation for Transcatheter Aortic Valve Replacement (TAVR) and Other Cardiac Procedures,” which will be chaired by Stanley J. ...

ByBioTrace Medical Inc


BioStable Surpasses 500 Patients Treated Worldwide with the HAART Devices

BioStable Surpasses 500 Patients Treated Worldwide with the HAART Devices

“Many cardiothoracic surgeons recognize that the young aortic insufficiency patient population cannot be treated with percutaneous aortic valve replacement devices and should be treated surgically with aortic valve repair whenever possible.[1] The HAART Aortic Annuloplasty Devices are ...

ByBioStable Science & Engineering, Inc.


Novostia technology for heart valve prosthesis raises CHF 6.5 million to start first clinical trials

Novostia technology for heart valve prosthesis raises CHF 6.5 million to start first clinical trials

Neuchâtel, Switzerland, February 22, 2019 – Novostia announces that it raised CHF 6.5 million from private investors to advance its disruptive aortic and mitral heart valve to clinical trials. Heart valve diseases affect more than 100 million people worldwide. Every year hundreds of thousands of ...

ByNovostia SA


Colibri Heart Valve to Present Patient Follow-up Results from Clinical Feasibility Study of Second-Generation TAVI System at TCT

Colibri Heart Valve to Present Patient Follow-up Results from Clinical Feasibility Study of Second-Generation TAVI System at TCT

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 ...

ByColibri Heart Valve LLC

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