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The first heart device of its kind | Stem cell patch impresses | FDA sees promise in new therapy | MAC linked to major risks

News You Need to Know Today
The first heart device of its kind | Stem cell patch impresses | FDA sees promise in new therapy | MAC linked to major risks
Monday, November 24, 2025
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Editor's Choice: Heart Failure

FDA panel to review first heart failure device of its kind

The shunt device being reviewed showed a 52% reduction in hospitalizations and favorable trends in mortality in patients with heart failure with reduced ejection fraction. 

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The V-Wave intra-atrial shunt to treat heart failure on display on the expo floor at ACC.24. The device was used in one of the late breaking trials at ACC. DF 3
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FDA panel to review first heart failure device of its kind

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The V-Wave intra-atrial shunt to treat heart failure on display on the expo floor at ACC.24. The device was used in one of the late breaking trials at ACC. DF 3
The shunt device being reviewed showed a 52% reduction in hospitalizations and favorable trends in mortality in patients with heart failure with reduced ejection fraction. 
READ MORE >

Stem cell patch shows potential to heal heart patients—no surgery or transplant required

The new patch is implanted through a tiny incision and held in place with a biocompatible adhesive. It then helps the heart recover over time, replacing dead tissue that would typically never be able to regenerate. 

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cardiologists evaluating the human heart to provide a treatment strategy
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Stem cell patch shows potential to heal heart patients—no surgery or transplant required

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cardiologists evaluating the human heart to provide a treatment strategy
The new patch is implanted through a tiny incision and held in place with a biocompatible adhesive. It then helps the heart recover over time, replacing dead tissue that would typically never be able to regenerate. 
READ MORE >

Large-scale policy changes fail to boost heart failure outcomes—what else is needed?

A system-wide initiative in Sweden helped hospitals reduce readmission rates and shorten lengths of stay. When it came to heart failure patients specifically, however, the changes barely made an impact.

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Hospital staff walking through a medical facility, intentionally blurred to look artistic
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Large-scale policy changes fail to boost heart failure outcomes—what else is needed?

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Hospital staff walking through a medical facility, intentionally blurred to look artistic
A system-wide initiative in Sweden helped hospitals reduce readmission rates and shorten lengths of stay. When it came to heart failure patients specifically, however, the changes barely made an impact.
READ MORE >

Transcaval access a safe, effective alternative during Impella implants

In some cases, researchers noted, cardiologists may need to rely on transcaval access during the treatment of a high-risk heart failure patient. 

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High-risk percutaneous coronary intervention (PCI) with an Impella heart pump is associated with better outcomes, including a significantly higher survival rate, than high-risk PCI with an intra-aortic balloon pump (IABP), according to new findings published in the American Journal of Cardiology. Impella Heart Pump Abiomed RECOVER IV RCT cardiogenic shock
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Transcaval access a safe, effective alternative during Impella implants

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High-risk percutaneous coronary intervention (PCI) with an Impella heart pump is associated with better outcomes, including a significantly higher survival rate, than high-risk PCI with an intra-aortic balloon pump (IABP), according to new findings published in the American Journal of Cardiology. Impella Heart Pump Abiomed RECOVER IV RCT cardiogenic shock
In some cases, researchers noted, cardiologists may need to rely on transcaval access during the treatment of a high-risk heart failure patient. 
READ MORE >

Oral heart failure drug receives FDA’s fast track designation

A clinical trial focused on patients with HFpEF is expected to be completed by July 2026.

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A majority of medical devices involved in Class I recalls were never required by the U.S. Food and Drug Administration (FDA) to undergo premarket or postmarket clinical testing, according to new research published in Annals of Internal Medicine.[1]
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Oral heart failure drug receives FDA’s fast track designation

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A majority of medical devices involved in Class I recalls were never required by the U.S. Food and Drug Administration (FDA) to undergo premarket or postmarket clinical testing, according to new research published in Annals of Internal Medicine.[1]
A clinical trial focused on patients with HFpEF is expected to be completed by July 2026.
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Mitral annular calcification linked to higher heart failure risks

In fact, researchers wrote, MAC appears to influence a patient's odds of developing HFpEF even more than their BMI.

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heart data research doctor cardiologist AI
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Mitral annular calcification linked to higher heart failure risks

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heart data research doctor cardiologist AI
In fact, researchers wrote, MAC appears to influence a patient's odds of developing HFpEF even more than their BMI.
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Transcatheter heart failure implant from Ancora Heart linked to positive 2-year data

The flexible device is attached to the inner wall of the left ventricle during a minimally invasive procedure. It was designed to reduce the size of the left ventricle over time.

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Ancora Heart AccuCinch Ventricular Restoration System heart failure FDA
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Transcatheter heart failure implant from Ancora Heart linked to positive 2-year data

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Ancora Heart AccuCinch Ventricular Restoration System heart failure FDA
The flexible device is attached to the inner wall of the left ventricle during a minimally invasive procedure. It was designed to reduce the size of the left ventricle over time.
READ MORE >

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