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Transcatheter Device Articles & Analysis

19 news found

Ancora Heart Receives Breakthrough Device Designation from FDA for the AccuCinch Ventricular Restoration System

Ancora Heart Receives Breakthrough Device Designation from FDA for the AccuCinch Ventricular Restoration System

This program is designed to ensure patients and healthcare providers have more timely access to these medical devices. As the only completely transcatheter procedure to treat the enlarged left ventricle, the AccuCinch System is a fundamentally different and innovative device-based therapy designed to improve the structure and function of the ...

ByAncora Heart, Inc


Cardiac Dimensions Included in the New 2021 ESC Guidelines for Heart Failure Management

Cardiac Dimensions Included in the New 2021 ESC Guidelines for Heart Failure Management

“And even more exciting is to have the allowance for other transcatheter valve therapy in the 2021 ESC valve guidelines with the Carillon device the only other device mentioned for use. ...

ByCardiac Dimensions, Inc.


Alleviant Medical Announces Presentation of Clinical Data at American College of Cardiology and EuroPCR Conferences

Alleviant Medical Announces Presentation of Clinical Data at American College of Cardiology and EuroPCR Conferences

Alleviant Medical Inc., a privately-held medical device company, today announced one-month and three-month follow up data from the first in human clinical study (ALLEVIATE-HF-1) of its technology for the treatment of heart failure with preserved ejection fraction (HFpEF). The Alleviant System is a novel transcatheter device for the creation of a ...

ByAlleviant Medical, Inc.


Cardiac Dimensions Announces Two New Meta-Analysis Publications Showing Statistically Significant and Clinically Meaningful Benefits to Heart Failure Patients Suffering from Functional Mitral Regurgitation

Cardiac Dimensions Announces Two New Meta-Analysis Publications Showing Statistically Significant and Clinically Meaningful Benefits to Heart Failure Patients Suffering from Functional Mitral Regurgitation

This publication, in addition to the several others recently published on the Carillon device, continues the series of excellent results for this transcatheter-based indirect annuloplasty device. ...

ByCardiac Dimensions, 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

Metcalf comes to JenaValve with over 30 years of experience in themedical device industry providing leadership in areas of regulatory affairs, clinical and quality assurance. ...

ByJenaValve Technology, Inc.


Alleviant Medical Receives Breakthrough Device Designation From FDA for Transcatheter Technology

Alleviant Medical Receives Breakthrough Device Designation From FDA for Transcatheter Technology

Alleviant Medical Inc., a privately-held medical device company, today announced that the US Food and Drug Administration (FDA) has granted the company a Breakthrough Device designation for its transcatheter technology. The technology offers a no-implant interatrial shunt therapy for patients suffering from heart failure with preserved (HFpEF) ...

ByAlleviant Medical, Inc.


BioVentrix Announces Jerry Estep, MD, as Co-Principal Investigator for ALIVE Pivotal Trial Studying a Transcatheter Device for Heart Failure

BioVentrix Announces Jerry Estep, MD, as Co-Principal Investigator for ALIVE Pivotal Trial Studying a Transcatheter Device for Heart Failure

BioVentrix, Inc., a privately held medical device company focused on treating congestive heart failure (CHF) via Transcatheter Ventricular Restoration (TCVR), today announced that heart failure specialist Jerry Estep, MD, of the Cleveland Clinic has been appointed co-principal investigator of the pivotal ALIVE Trial studying LIVE Therapy using the Revivent TC ...

ByBioVentrix, Inc.


BioVentrix Announces Pivotal ALIVE Trial Resumes with First Patients Treated with LIVE Therapy Since COVID-19 Pause

BioVentrix Announces Pivotal ALIVE Trial Resumes with First Patients Treated with LIVE Therapy Since COVID-19 Pause

BioVentrix, Inc., developer of the first hybrid transcatheter device for left ventricular remodeling after a heart attack, today announced that the Company has resumed cases in the pivotal ALIVE Trial studying Less Invasive Ventricular Enhancement, or LIVE™ Therapy, using the Revivent TC™ Transcatheter Ventricular Enhancement System. ...

ByBioVentrix, Inc.


Cardiac Dimensions Announces Australian Therapeutic Goods Administration’s Approval of the Carillon System for the Treatment of Functional Mitral Regurgitation

Cardiac Dimensions Announces Australian Therapeutic Goods Administration’s Approval of the Carillon System for the Treatment of Functional Mitral Regurgitation

The Carillon System is a right heart transcatheter mitral valve repair (TMVr) device designed to treat the primary cause of FMR in patients with mitral regurgitation grades 2+, 3+ and 4+. ...

ByCardiac Dimensions, Inc.


FierceMedTech Names BioVentrix as One of Its “Fierce 15” Companies of 2019

FierceMedTech Names BioVentrix as One of Its “Fierce 15” Companies of 2019

BioVentrix, Inc., developer of the first hybrid transcatheter device for left ventricular remodeling after a heart attack, today announced that it has been named by FierceMedTech as one of the “Fierce 15” for 2019, designating it as one of the most promising private medtech companies in the industry. ...

ByBioVentrix, Inc.


BioVentrix Announces Ralph Stephan von Bardeleben, MD, as Co- Principal Investigator of the REVIVE-HF Clinical Trial

BioVentrix Announces Ralph Stephan von Bardeleben, MD, as Co- Principal Investigator of the REVIVE-HF Clinical Trial

BioVentrix, Inc., developer of the first transcatheter device for left ventricular remodeling after a heart attack, today announced that Ralph Stephan von Bardeleben, MD, of the University Medical Center of Mainz (Germany) has joined the European REVIVE-HF clinical trial of the Revivent TC™ Transcatheter Ventricular Enhancement System as ...

ByBioVentrix, Inc.


New Data Confirms Cardiac Dimensions’ Carillon System Shows Favorable Long-Term Survival Rate in Patients with Functional Mitral Regurgitation

New Data Confirms Cardiac Dimensions’ Carillon System Shows Favorable Long-Term Survival Rate in Patients with Functional Mitral Regurgitation

Janusz Lipiecki, a cardiologist in the Center for Interventional Cardiology of Pôle Santé République in Clermont-Ferrand, France, presented the data on behalf of all TITAN, TITAN II and REDUCE FMR clinical study investigators and commented “The recent publication of the REDUCE FMR data demonstrated a significant reduction in regurgitant volume and favorable left ...

ByCardiac Dimensions, 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. ...

ByJenaValve Technology, Inc.


REDUCE FMR Study Shows Cardiac Dimensions’ Carillon System Significantly Improves Mitral Regurgitation and Slows Worsening of Heart Failure

REDUCE FMR Study Shows Cardiac Dimensions’ Carillon System Significantly Improves Mitral Regurgitation and Slows Worsening of Heart Failure

The Carillon System is a right heart transcatheter mitral valve repair (TMVr) device designed to treat the primary cause of FMR in patients with MR grades 2+, 3+ and 4+. ...

ByCardiac Dimensions, Inc.


Cardiac Dimensions Reaches 1,000 Implants of Carillon System, a Minimally Invasive Treatment for Functional Mitral Regurgitation

Cardiac Dimensions Reaches 1,000 Implants of Carillon System, a Minimally Invasive Treatment for Functional Mitral Regurgitation

The Carillon System is a right-heart transcatheter mitral valve repair (TMVr) device designed to treat the primary cause of FMR in patients with MR grades 2+, 3+ and 4+. ...

ByCardiac Dimensions, Inc.


New Data Shows The Carillon Mitral Contour System Is Associated With Improvement In Regurgitant Volume In Patients With Increased Mitral Valve Tenting

New Data Shows The Carillon Mitral Contour System Is Associated With Improvement In Regurgitant Volume In Patients With Increased Mitral Valve Tenting

The Carillon System is a right-heart transcatheter mitral valve repair (TMVr) device designed to treat the primary cause of FMR in patients with MR grades 2+, 3+ and 4+. ...

ByCardiac Dimensions, Inc.


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

About the Colibri Heart Valve and the Ready-to-Use Colibri TAVI System Colibri Heart Valve LLC is a privately held medical device company based in Broomfield, CO that researches and develops novel heart valve technologies. Colibri has developed a pre-mounted, pre-crimped, and pre-packaged, ready-for-use transcatheter aortic valve implantation (TAVI) ...

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

Colibri Heart Valve LLC, a privately held emerging medical device company, has received an Issue Notification from the U.S. Patent and Trademark Office regarding the forthcoming granting of U.S. ...

ByColibri Heart Valve LLC

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