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Aortic Stenosis Articles & Analysis

13 news found

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

An average 86% improvement in mean gradient (standard measure of stenosis severity) from pre-treatment levels. Mean gradients were up to 50% lower than other TAVR devices when matched to annular size(1). ...

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

Under the terms of the agreement, Peijia has made a cash and equity investment in JenaValve and will commit additional capital and royalty payments based upon various milestone achievements in exchange for exclusive rights to develop and commercialize JenaValve’s innovative Trilogy TAVR systems in the Greater China region to treat patients suffering from either severe symptomatic ...

ByJenaValve Technology, Inc.


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 procedures for all ...

ByAnteris Technologies Limited


DurAVR accepted into TCT innovation session

DurAVR accepted into TCT innovation session

“Being recognized by the selection committee in this highly competitive component of TCT is further validation of how clinically relevant DurAVRTM is for the treatment of younger patients with aortic stenosis. The unique hemodynamic profile, ADAPT® premium and proven superior anti-calcification treatment, and novel 3D unibody design, giving greater ...

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

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 European commercial launch of Trilogy. The Trilogy Heart Valve System is the first and only transfemoral TAVR system in the world indicated for the treatment of aortic ...

ByJenaValve Technology, Inc.


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 TrilogyTM Heart Valve System for the treatment of ...

ByJenaValve Technology, 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

Food and Drug Administration (FDA), which allows for priority review of our Align Clinical Trial for the treatment of symptomatic, severe aortic regurgitation (AR) and AR-dominant mixed aortic valve disease. ...

ByJenaValve Technology, Inc.


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

Fish stated, “The post-implantation measures of aortic valve pressure gradients and paravalvular leakage continue to be favorable at six months following implantation. ...

ByColibri Heart Valve LLC


Colibri Heart Valve Continues Enrollment in Clinical Feasibility Study of Second-Generation TAVI System

Colibri Heart Valve Continues Enrollment in Clinical Feasibility Study of Second-Generation TAVI System

Initial post-implantation results from these patients, who received a 24mm valve, show favorable low aortic valve pressure gradients and no observed paravalvular leakage or aortic insufficiency. ...

ByColibri Heart Valve LLC


Colibri Heart Valve Advances Second-Generation TAVI System into Clinical Feasibility Study

Colibri Heart Valve Advances Second-Generation TAVI System into Clinical Feasibility Study

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 ...

ByColibri Heart Valve LLC


Colibri Heart Valve Forms a New Entity to Monetize Tissue Processing Technology in Applications Outside of Structural Heart

Colibri Heart Valve Forms a New Entity to Monetize Tissue Processing Technology in Applications Outside of Structural Heart

The Colibri TAVI System has been successfully tested in a first-in-human study in patients with severe symptomatic aortic valve stenosis who are deemed very high risk for open-heart valve replacement surgery. ...

ByColibri Heart Valve LLC


Colibri Heart Valve Forms a New Entity to Monetize Tissue Processing Technology in Applications Outside of Structural Heart

Colibri Heart Valve Forms a New Entity to Monetize Tissue Processing Technology in Applications Outside of Structural Heart

The Colibri TAVI System has been successfully tested in a first-in-human study in patients with severe symptomatic aortic valve stenosis who are deemed very high risk for open-heart valve replacement surgery. ...

ByColibri Heart Valve LLC

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