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Transcatheter Aortic Valve Implantation Articles & Analysis

13 news found

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 performed the full gamut of adult cardiac surgery procedures, with a special focus on minimally invasive procedures, including catheter-based structural heart techniques and served as transcatheter aortic valve implantation (TAVI) international proctor for Edwards Lifesciences. ...

ByCytoSorbents Corporation


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.


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.


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, ...

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

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 ...

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

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 ...

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 ...

ByColibri Heart Valve LLC


Colibri Heart Valve Announces Issuance of a Patent for a Pre-mounted, Pre-packaged, Sterilized Dry Heart Valve on a Delivery System

Colibri Heart Valve Announces Issuance of a Patent for a Pre-mounted, Pre-packaged, Sterilized Dry Heart Valve on a Delivery System

Colibri Heart Valve, LLC, a privately held medical device company, has been granted yet another patent directed to prosthetic heart valves. More particularly, today the U.S. Patent & Trademark Office granted Colibri U.S. Patent No. 8,361,144 entitled, “Percutaneously Deliverable Heart Valve Device And Methods Associated Therewith.” The patent is directed to a method of making a ...

ByColibri Heart Valve LLC


Colibri Heart Valve Receives ISO 13485 and EN ISO 13485 Certification

Colibri Heart Valve Receives ISO 13485 and EN ISO 13485 Certification

Colibri Heart Valve LLC, a privately held emerging medical device company focused on structural heart applications, announced today that it has received certification from DEKRA Certification B.V. that the company complies with the European requirements of ISO 13485 and EN ISO 13485 for a comprehensive quality management system for the design and manufacture of the ...

ByColibri Heart Valve LLC


Colibri Heart Valve Receives European Patent for a Method of Making a Pre-packaged, Sterilized Dry Heart Valve, Pre-mounted on a Delivery Catheter

Colibri Heart Valve Receives European Patent for a Method of Making a Pre-packaged, Sterilized Dry Heart Valve, Pre-mounted on a Delivery Catheter

” A pre-packaged, ready-for-use, THV System provides significant time and cost benefits associated with a transcatheter heart valve replacement procedure and is ideally suited for expanding the use of this treatment modality into emerging world markets. ...

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

Colibri Heart Valve LLC, a privately held emerging medical device company focused on structural heart applications, announces the formation of a new company called Colorado Therapeutics LLC. In conjunction with its formation, Colibri has granted Colorado Therapeutics a license to develop and market innovative and disruptive xenogenic (sourced from different mammalian species) biologic tissue ...

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

Colibri Heart Valve LLC, a privately held emerging medical device company focused on structural heart applications, announces the formation of a new company called Colorado Therapeutics LLC. In conjunction with its formation, Colibri has granted Colorado Therapeutics a license to develop and market innovative and disruptive xenogenic (sourced from different mammalian species) biologic tissue ...

ByColibri Heart Valve LLC


Colibri Heart Valve Strengthens Patent Portfolio with Receipt of 12th Transcatheter Heart Valve (THV) Patent

Colibri Heart Valve Strengthens Patent Portfolio with Receipt of 12th Transcatheter Heart Valve (THV) Patent

“This soon-to-issue patent covers a percutaneous replacement heart valve and a delivery and implantation system with a priority date of 2002 that is both early and meaningful in the transcatheter heart valve ...

ByColibri Heart Valve LLC

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