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Chronic Heart Failure Articles & Analysis

41 news found

Sequana Medical completes enrollment in Phase 2a SAHARA I DSR study, reports disease-modifying profile for Short Term DSR and provides business update

Sequana Medical completes enrollment in Phase 2a SAHARA I DSR study, reports disease-modifying profile for Short Term DSR and provides business update

DSR (Direct Sodium Removal) heart failure drug development: Completed enrollment in SAHARA I[i] with first-generation DSR product (“DSR 1.0”) – extending study with second-generation DSR product (“DSR 2.0”) to support US IND[ii] filing by year end Proof-of-concept delivered in diuretic-resistant heart failure patients with dramatic and durable improvements in ...

BySequana Medical NV


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

– July 12, 2022 – Ancora Heart, Inc., a company developing a novel device-based therapy to address heart failure, today announced that the U.S. ...

ByAncora Heart, Inc


Procyrion Selects Former Abbott/St. Jude Medical Group President Dr. Eric S. Fain as CEO

Procyrion Selects Former Abbott/St. Jude Medical Group President Dr. Eric S. Fain as CEO

Procyrion, Inc., a medical device company developing a catheter-deployed micropump for the management of chronic heart failure, has named Eric S. Fain, MD as President and Chief Executive Officer effective immediately. ...

ByProcyrion, Inc.


CVRx Announces First Clinical Procedure with a New Ultrasound-Guided Implant Approach, the Latest Advancement in Barostim™ for the Treatment of Heart Failure Symptoms

CVRx Announces First Clinical Procedure with a New Ultrasound-Guided Implant Approach, the Latest Advancement in Barostim™ for the Treatment of Heart Failure Symptoms

Barostim is also the recipient of the Centers for Medicare and Medicaid Services (CMS) outpatient Transitional Pass-Through Payment Status (TPT) and inpatient New Technology Add-On Payment (NTAP). About Heart Failure Heart failure is a chronic, progressive condition in which the heart muscle is ...

ByCVRx


CVRx Receives MR-Conditional Labeling Approval for its Barostim Heart Failure System

CVRx Receives MR-Conditional Labeling Approval for its Barostim Heart Failure System

Heart failure is a chronic, progressive condition in which the heart muscle is unable to pump enough blood to meet the body's needs for blood and oxygen. ...

ByCVRx


BioCardia Announces FDA Approval of Its IND for NK1R+ Mesenchymal Stem Cells for the Treatment of Patients Recovering from Acute Respiratory Distress due to COVID-19

BioCardia Announces FDA Approval of Its IND for NK1R+ Mesenchymal Stem Cells for the Treatment of Patients Recovering from Acute Respiratory Distress due to COVID-19

” "In addition to our critically important autologous cell therapies being studied for ischemic heart failure and chronic myocardial ischemia with refractory angina, the FDA's acceptance of this IND for patients recovering from ARDS is an important milestone in the development of our allogeneic mesenchymal stem cell therapy platform and ...

ByBiocardia, Inc.


BioCardia Announces New Center for Medicare and Medicaid Services Reimbursement Code Applicable to the CardiAMP Cell Therapy Procedure

BioCardia Announces New Center for Medicare and Medicaid Services Reimbursement Code Applicable to the CardiAMP Cell Therapy Procedure

The code provides clear reimbursement for the study procedure performed for both the treatment and control arms for the ongoing cell therapy pivotal trials in two cardiovascular indications: the CardiAMP Cell Therapy Heart Failure Trial (NCT02438306) and the CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial (NCT03455725). ...

ByBiocardia, Inc.


BioCardia Announces Positive DSMB Review and Recommendation to Continue Phase III Pivotal CardiAMP Cell Therapy Heart Failure Study as Designed

BioCardia Announces Positive DSMB Review and Recommendation to Continue Phase III Pivotal CardiAMP Cell Therapy Heart Failure Study as Designed

The DSMB consists of two world renowned cardiologists with experience in heart failure and interventional cardiology, as well as a world-renowned biostatistician with considerable experience evaluating trial data for chronic diseases, including heart failure. ...

ByBiocardia, Inc.


New Phase III study to investigate expanded use of vericiguat in patients with chronic heart failure with reduced ejection fraction

New Phase III study to investigate expanded use of vericiguat in patients with chronic heart failure with reduced ejection fraction

New Phase III study VICTOR will assess vericiguat efficacy and safety in patients who have not had a recent worsening heart failure event / VICTOR expands upon the Phase III VICTORIA study, providing further insight into the use of vericiguat in a broader range of patients with chronic heart failure with reduced ...

ByBayer AG


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

Cardiac Dimensions, a leader in the development of innovative, minimally invasive treatment modalities to address heart failure and related cardiovascular conditions, today announced the mention of their Carillon Mitral Contour System in the 2021 European Society of Cardiology (ESC) Guidelines for the Diagnosis and Treatment of Acute and Chronic ...

ByCardiac Dimensions, Inc.


FDA Grants EBR Systems Breakthrough Device Designation Status for the WiSE Cardiac Resynchronization Therapy (CRT) System

FDA Grants EBR Systems Breakthrough Device Designation Status for the WiSE Cardiac Resynchronization Therapy (CRT) System

About Heart Failure and Cardiac Resynchronization Therapy (CRT) Heart failure is a serious condition in which the heart is unable to pump enough blood to meet the body’s demands. ...

ByEBR Systems, Inc.


Procyrion Announces Successful First-In-Human Cases in Cardiorenal Syndrome (CRS) Patients with Aortix™ Percutaneous Mechanical Circulatory Support Device

Procyrion Announces Successful First-In-Human Cases in Cardiorenal Syndrome (CRS) Patients with Aortix™ Percutaneous Mechanical Circulatory Support Device

“With CRS, low blood flow to the kidneys, as a result of underlying heart failure, causes activation of the neurohormonal system and signals the body to retain fluid, further straining the heart and exacerbating heart failure. ...

ByProcyrion, Inc.


Intersect ENT Receives CE Mark Approval for PROPEL Contour for Patients with Chronic Rhinosinusitis Following Frontal Sinus Surgery

Intersect ENT Receives CE Mark Approval for PROPEL Contour for Patients with Chronic Rhinosinusitis Following Frontal Sinus Surgery

PROPEL Contour features an innovative hourglass shape, specifically designed for placement in the frontal sinuses (between the eyebrows) following sinus surgery for chronic rhinosinusitis patients. The implant features a low-profile flexible delivery system to make it easier to access areas of the frontal sinus ostia. ...

ByIntersect ENT, Inc.


The Ultimate List of Attractive MedTech M&A Targets

The Ultimate List of Attractive MedTech M&A Targets

Endotronix Endotronix is developing an integrated platform to provide comprehensive, reimbursable health management tools for patients suffering from chronic heart failure. The company’s comprehensive solution includes a cloud-based disease management data system and outpatient hemodynamic management with a breakthrough implantable ...

ByAnuncia Medical, Inc.


World’s First Leadless Left Bundle Branch Area Pacing Implant Utilizing EBR Systems’ WiSE CRT System

World’s First Leadless Left Bundle Branch Area Pacing Implant Utilizing EBR Systems’ WiSE CRT System

We look forward to building on this clinical experience.” About Heart Failure and Cardiac Resynchronization Therapy (CRT) Heart failure is a serious condition in which the heart is unable to pump enough blood to meet the body’s demands. ...

ByEBR Systems, Inc.


Endotronix Appoints Industry Veteran Dan Dearen to Board of Directors

Endotronix Appoints Industry Veteran Dan Dearen to Board of Directors

And I look forward to leveraging my diverse experiences to accelerate the company along its mission to transform the standard of care for chronic heart failure patients.” The Cordella™ Heart Failure System from Endotronix is a comprehensive heart failure management ...

ByEndotronix, Inc.


Alleviant Medical Receives Breakthrough Device Designation From FDA for Transcatheter Technology

Alleviant Medical Receives Breakthrough Device Designation From FDA for Transcatheter Technology

The technology offers a no-implant interatrial shunt therapy for patients suffering from heart failure with preserved (HFpEF) and mid-range ejection fraction (HFmrEF) who remain symptomatic despite optimal guideline directed medical therapy. ...

ByAlleviant Medical, Inc.


CVRx`s BAROSTIM NEO Receives CMS NTAP Effective October 1, 2020

CVRx`s BAROSTIM NEO Receives CMS NTAP Effective October 1, 2020

MINNEAPOLIS, Nov. 2, 2020 - CVRx®, developer of the world's first FDA-approved neuromodulation device to treat chronic heart failure (HF), announces that its BAROSTIM NEO™ implantable device has received the Centers for Medicare & Medicaid Services (CMS) inpatient New Technology Add-On Payment (NTAP). ...

ByCVRx


Cardior Pharmaceuticals ´ Lead Compound Demonstrates Improvement of Heart Function in Chronic Heart Failure Mode

Cardior Pharmaceuticals ´ Lead Compound Demonstrates Improvement of Heart Function in Chronic Heart Failure Mode

Hanover, Germany, October 22, 2020 - Cardior Pharmaceuticals GmbH, a clinical-stage biotech company, focused on the development of noncoding RNA (ncRNA) therapeutics for patients with cardiovascular diseases, today announced a publication in the European Heart Journal (doi:10.1093/eurheartj/ehaa791) demonstrating that repeated treatment with its lead compound CDR132L is safe, ...

ByCardior Pharmaceuticals GmbH


RemetricHealth’s Integrated Telehealth/Remote Patient Monitoring Solutions Bridge the Gap Between Patients and Providers Amid Ongoing COVID-19 Crisis

RemetricHealth’s Integrated Telehealth/Remote Patient Monitoring Solutions Bridge the Gap Between Patients and Providers Amid Ongoing COVID-19 Crisis

“Visual check-ins via telehealth alone aren’t enough; If you don’t also have a way to adopt preventive measures and keep an eye on biometric data remotely, patients will experience complications of chronic conditions,” says Wayne Meng, CEO and founder of RemetricHealth. ...

ByRemetricHealth

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