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Aortic Regurgitation Articles & Analysis

7 news found

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.


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 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 risk 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

Food and Drug Administration (FDA), which allows for priority review of the ALIGN Clinical Trial for the treatment of symptomatic, severe aortic regurgitation (AR) and AR-dominant mixed aortic valve disease.JenaValve’s TAVR System is differentiated in that no other transcatheter valve device is currently available for patients suffering ...

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.


BioStable Surpasses 500 Patients Treated Worldwide with the HAART Devices

BioStable Surpasses 500 Patients Treated Worldwide with the HAART Devices

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. ...

ByBioStable Science & Engineering, Inc.

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