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Valve Implant Articles & Analysis

24 news found

CONVERT Clinical Trial Data Presented at ERS Demonstrates Early Success of AeriSeal System in Patients with Advanced COPD/Emphysema

CONVERT Clinical Trial Data Presented at ERS Demonstrates Early Success of AeriSeal System in Patients with Advanced COPD/Emphysema

Once the treated lobe tests negative for collateral ventilation (CV-), Zephyr Valves are implanted to address hyperinflation of that target lobe to ease emphysema symptoms without major surgery. ...

ByPulmonx Corporation


Confluent Medical Technologies Announces Grand Opening of Costa Rica Expansion

Confluent Medical Technologies Announces Grand Opening of Costa Rica Expansion

Confluent’s engineered solutions to the most challenging design problems enable our OEM medical device customers to offer life-saving implantable products. Our customers rely on Confluent for materials science and associated manufacturing expertise which is critical to the function and value of their most demanding, high growth products – proprietary expertise which ...

ByConfluent Medical Technologies


enVVeno Medical Appoints Kevin Belteau as Vice President of Clinical Operations

enVVeno Medical Appoints Kevin Belteau as Vice President of Clinical Operations

The VenoValve® is bioprosthetic valve that is surgically implanted into the femoral vein as a potential treatment for deep venous CVI. ...

ByenVVeno Medical


enVVeno Medical Announces the Issuance of a New Unique Category III CPT Code Covering the Insertion of a Bioprosthetic Valve into the Femoral Vein

enVVeno Medical Announces the Issuance of a New Unique Category III CPT Code Covering the Insertion of a Bioprosthetic Valve into the Femoral Vein

” The VenoValve® is bioprosthetic valve that is surgically implanted into the femoral vein as a potential treatment for deep venous CVI. ...

ByenVVeno Medical


InnovHeart appoints David Wilson as Chief Executive Officer

InnovHeart appoints David Wilson as Chief Executive Officer

“I am excited to join the talented team at InnovHeart at this pivotal time of focus and commitment to significantly advancing Transcatheter Mitral Valve Replacement (TMVR) procedures enabled by our transformational Saturn platform,” said Mr. ...

ByInnovHeart Srl.


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

This is a 170% greater improvement than observed in studies of other TAVR valves(3). This indicates a marked improvement in patients’ functional status and exercise tolerance. ...

ByAnteris Technologies Limited


Confluent Medical Announces Significant Strategic Investment From TPG

Confluent Medical Announces Significant Strategic Investment From TPG

Confluent supports the design, development and manufacturing of life-saving implants, minimally invasive delivery systems and other medical devices utilized in some of the most innovative and technologically challenging applications in the medical device industry. ...

ByConfluent Medical Technologies


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


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. ...

ByAnteris Technologies Limited


Xeltis lands €15 million European financing from EIB

Xeltis lands €15 million European financing from EIB

” Eliane Schutte, Xeltis CEO, added: “EIB financial support can make the difference in the time our restorative heart valves and blood vessels reach patients that today have limited or no options at all for their conditions. ...

ByXELTIS BV


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.


You live and learn

You live and learn

Together with him, we have evaluated in which part of a transcatheter heart valve implantation our navigation technology could provide benefits. ...

ByNDI Europe GmbH


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 regurgitation. 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 ...

ByJenaValve Technology, Inc.


BioStable Surpasses 500 Patients Treated Worldwide with the HAART Devices

BioStable Surpasses 500 Patients Treated Worldwide with the HAART Devices

While patients have benefited from advances in mitral valve repair procedures for decades, reproducing the same positive results ─ long-term durability, freedom from re-operation and normal life expectancy ─ using aortic valve repair techniques has been challenging. ...

ByBioStable Science & Engineering, 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 Transcatheter Cardiovascular Therapeutics (TCT) ...

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 post-implantation results from ...

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. ...

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. ...

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

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