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Cardiac Survival Articles & Analysis

6 news found

BioCardia Receives No Objection Letter from Health Canada, Enabling Company to Expand CardiAMP Cell Therapy Heart Failure Trial into Canada

BioCardia Receives No Objection Letter from Health Canada, Enabling Company to Expand CardiAMP Cell Therapy Heart Failure Trial into Canada

The CardiAMP Cell Therapy Heart Failure Trial is evaluating the effectiveness of the CardiAMP Cell Therapy System for improving survival, reducing major adverse cardiac events, enhancing functional capacity, and improving quality of life for New York Heart Association (NYHA) Class II and III patients who have heart failure associated with ischemic cardiomyopathy. ...

ByBiocardia, Inc.


BioCardia Receives FDA Breakthrough Device Designation for CardiAMP Cell Therapy System for Heart Failure

BioCardia Receives FDA Breakthrough Device Designation for CardiAMP Cell Therapy System for Heart Failure

It is believed to be the first cardiac cell therapy to receive FDA Breakthrough Device status. CardiAMP Cell Therapy uses a patient’s own (autologous) bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure. The therapy incorporates a pre-procedural screening assay to identify patients who may be likely responders, a first for a ...

ByBiocardia, Inc.


Neurescue`s Breakthrough Intelligent Balloon Catheter FDA 510(k) Cleared for Hemorrhage Control and IDE Approved for Cardiac Arrest

Neurescue`s Breakthrough Intelligent Balloon Catheter FDA 510(k) Cleared for Hemorrhage Control and IDE Approved for Cardiac Arrest

Today, only 1 out of 10 survive a cardiac arrest with the current treatment and it is estimated to be the single largest cause of death worldwide.2 Neurescue aims for its device to help increase the survival rate for these patients. ...

ByNeurescue


1 out of 10 survive cardiac arrest, a new device under FDA review hopes to change that

1 out of 10 survive cardiac arrest, a new device under FDA review hopes to change that

KEY POINTS Cardiac arrest is one of the leading causes of death in the U.S. and globally. It has a survival rate of 1 in 10 people with current treatment. The Neurescue device is designed to increase blood flow to the brain and heart during life-threatening emergencies such as cardiac arrest. ...

ByNeurescue


Celixir announces US FDA approval of the IND application for cell therapy Heartcell

Celixir announces US FDA approval of the IND application for cell therapy Heartcell

About Heartcel Heartcell is an allogeneic cell therapy containing off-the-shelf immunomodulatory progenitor (iMP) cells engineered to regenerate the heart. iMPs are administered during coronary artery bypass graft (CABG) surgery by direct injection around the cardiac scar that is to be regenerated. iMP cells have been designated an Advanced Therapeutic Medicinal Product (ATMP) by ...

ByCelixir plc


CTA approval for potentially pivotal Heartcel Phase IIb trial

CTA approval for potentially pivotal Heartcel Phase IIb trial

Heartcel, Celixir’s lead investigational cardiac regenerative medicine, is a tissue engineered medicine comprising allogeneic (off-the-shelf) immunomodulatory progenitor (iMP) cells and is designated as an advanced therapeutic medicinal product (ATMP) by the European Medicines Agency. iMP cells are a novel cell type engineered to reduce heart scarring and regenerate the ...

ByCelixir plc

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