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FDA sees promise in total artificial heart tech | Why surgery trials need more diversity | New-look peripheral stent approved

News You Need to Know Today
FDA sees promise in total artificial heart tech | Why surgery trials need more diversity | New-look peripheral stent approved
Monday, June 2, 2025
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Today's News and Trends

FDA sees promise in new total artificial heart technology, granting it ‘breakthrough’ status

The device was built as a bridge to transplant for patients with end-stage heart failure. It is made of titanium and approximately the size of an adult’s fist.

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Surgeons in Houston have performed the world’s first successful human implant of BiVacor’s Total Artificial Heart (TAH) technology. The procedure was completed July 9, 2024, at The Texas Heart Institute at Baylor St. Luke’s Medical Center. It was part of an early feasibility study (EFS) first approved by the U.S. Food and Drug Administration (FDA) back in December 2023. BiVacor has received the FDA’s breakthrough device designation for its titanium Total Artificial Heart (TAH).
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FDA sees promise in new total artificial heart technology, granting it ‘breakthrough’ status

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Surgeons in Houston have performed the world’s first successful human implant of BiVacor’s Total Artificial Heart (TAH) technology. The procedure was completed July 9, 2024, at The Texas Heart Institute at Baylor St. Luke’s Medical Center. It was part of an early feasibility study (EFS) first approved by the U.S. Food and Drug Administration (FDA) back in December 2023. BiVacor has received the FDA’s breakthrough device designation for its titanium Total Artificial Heart (TAH).
The device was built as a bridge to transplant for patients with end-stage heart failure. It is made of titanium and approximately the size of an adult’s fist.
READ MORE >

The lack of diversity in cardiac surgery trials may be harmful to patients

Mario Gaudino, MD, PhD, told Cardiovascular Business there is a major need for more women and minorities in today's clinical trials.

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Mario Gaudino, MD, explains why cardiac surgery trials need more diversity to better inform treatment decisions for women and minorities.
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The lack of diversity in cardiac surgery trials may be harmful to patients

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Mario Gaudino, MD, explains why cardiac surgery trials need more diversity to better inform treatment decisions for women and minorities.
Mario Gaudino, MD, PhD, told Cardiovascular Business there is a major need for more women and minorities in today's clinical trials.
READ MORE >

New-look peripheral stent with expandable spikes receives FDA’s de novo classification

California-based Reflow Medical gained the approval after submitting data from the DEEPER REVEAL clinical trial. The device was associated with a high success rate and improved outcomes in CLTI patients.

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Reflow Medical Spur Peripheral Retrievable Stent System. Reflow Medical, a California-based medtech company focused on cardiovascular disease treatments, has received the FDA’s de novo classification for its Spur Peripheral Retrievable Stent System. De novo classification represents an alternative pathway to gaining FDA approval when no comparable devices are currently available.
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New-look peripheral stent with expandable spikes receives FDA’s de novo classification

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Reflow Medical Spur Peripheral Retrievable Stent System. Reflow Medical, a California-based medtech company focused on cardiovascular disease treatments, has received the FDA’s de novo classification for its Spur Peripheral Retrievable Stent System. De novo classification represents an alternative pathway to gaining FDA approval when no comparable devices are currently available.
California-based Reflow Medical gained the approval after submitting data from the DEEPER REVEAL clinical trial. The device was associated with a high success rate and improved outcomes in CLTI patients.
READ MORE >

Featured Articles

Private equity's influence continues to rise in cardiology—what does that mean for patient care?

Rishi Wadhera, MD, MPP, MPhil, a cardiologist who also specializes in healthcare policy, spoke to Cardiovascular Business about the good, the bad and the unknown when it comes to private equity's role in cardiology.

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Rishi Wadhera, MD, MPP, MPhil, associate director of the Richard A. and Susan F. Smith Center for Outcomes Research, Beth Israel Deaconess Medical Center, and an associate professor of health policy and management, Harvard School of Public Health, explains the impact of private equity ownership of hospitals and private practices.
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Private equity's influence continues to rise in cardiology—what does that mean for patient care?

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Rishi Wadhera, MD, MPP, MPhil, associate director of the Richard A. and Susan F. Smith Center for Outcomes Research, Beth Israel Deaconess Medical Center, and an associate professor of health policy and management, Harvard School of Public Health, explains the impact of private equity ownership of hospitals and private practices.
Rishi Wadhera, MD, MPP, MPhil, a cardiologist who also specializes in healthcare policy, spoke to Cardiovascular Business about the good, the bad and the unknown when it comes to private equity's role in cardiology.
READ MORE >

How anticoagulants may impact a patient’s risk of gastrointestinal bleeding after TAVR

Researchers tracked the rates of major gastrointestinal bleeding in patients with AFib randomized to receive edoxaban or a vitamin K antagonist after a successful TAVR procedure.

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heart drugs with stethoscope
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How anticoagulants may impact a patient’s risk of gastrointestinal bleeding after TAVR

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heart drugs with stethoscope
Researchers tracked the rates of major gastrointestinal bleeding in patients with AFib randomized to receive edoxaban or a vitamin K antagonist after a successful TAVR procedure.
READ MORE >

Terumo Interventional Systems launches dual-layer micromesh carotid stent after FDA approval

The dual-layer micromesh stent was designed with the flexibility of an open-cell stent and is available in multiple sizes.

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Roadsaver Carotid Stent System
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Terumo Interventional Systems launches dual-layer micromesh carotid stent after FDA approval

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Roadsaver Carotid Stent System
The dual-layer micromesh stent was designed with the flexibility of an open-cell stent and is available in multiple sizes.
READ MORE >

SCAI celebrates legacies of pioneer pediatric cardiologists

Five veteran clinicians have been recognized for their lasting impact on the field of pediatric cardiology. 

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Compensation for U.S. cardiologists is up across the board, according to a recent survey published by MedAxiom, an American College of Cardiology company. The report identified similar trends for cardiovascular surgeons, highlighting the country’s high demand for all heart specialists in 2024 and beyond.
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SCAI celebrates legacies of pioneer pediatric cardiologists

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Compensation for U.S. cardiologists is up across the board, according to a recent survey published by MedAxiom, an American College of Cardiology company. The report identified similar trends for cardiovascular surgeons, highlighting the country’s high demand for all heart specialists in 2024 and beyond.
Five veteran clinicians have been recognized for their lasting impact on the field of pediatric cardiology. 
READ MORE >

In Case You Missed It

Cardiology employment models undergoing a dramatic shift

Gerald G. Blackwell, MD, MBA, MedAxiom's president and CEO, examined how different cardiology employment models look today compared to even a decade ago.

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Gerald Blackwell, president and CEO of MedAxiom, discusses the business of cardiology at ACC 2025.
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Cardiology employment models undergoing a dramatic shift

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Gerald Blackwell, president and CEO of MedAxiom, discusses the business of cardiology at ACC 2025.
Gerald G. Blackwell, MD, MBA, MedAxiom's president and CEO, examined how different cardiology employment models look today compared to even a decade ago.
READ MORE >

AI delivers real-time blood clot monitoring, helping cardiologists make treatment decisions

Researchers have used a state-of-the-art microscope and advanced AI to track clotting risks in CAD patients. The goal is to spot blood clots before they even happen, ensuring patients are prescribed the right therapy for their specific needs. 

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robot reviewing heart data
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AI delivers real-time blood clot monitoring, helping cardiologists make treatment decisions

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robot reviewing heart data
Researchers have used a state-of-the-art microscope and advanced AI to track clotting risks in CAD patients. The goal is to spot blood clots before they even happen, ensuring patients are prescribed the right therapy for their specific needs. 
READ MORE >

Original Banksy artwork headed to auction—proceeds will help fund heart research

The piece in question, which features a red heart-shaped balloon, has an unusual origin story, even by Banksy’s standards. 

READ MORE >
Banksy art auction American Heart Association
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Original Banksy artwork headed to auction—proceeds will help fund heart research

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Banksy art auction American Heart Association
The piece in question, which features a red heart-shaped balloon, has an unusual origin story, even by Banksy’s standards. 
READ MORE >

In Other News

Healthcare AI newswatch: MAHA’s AI stumble, OpenAI’s healthcare offensive, Mayo’s AI startup support, more

Mayo Clinic is looking to give promising medtech startups a seriously running start. Toward that end, the august institution has launched the new Mayo Venture Partner program. 

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mayo clinic AI startup support
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Healthcare AI newswatch: MAHA’s AI stumble, OpenAI’s healthcare offensive, Mayo’s AI startup support, more

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mayo clinic AI startup support
Mayo Clinic is looking to give promising medtech startups a seriously running start. Toward that end, the august institution has launched the new Mayo Venture Partner program. 
READ MORE >

FDA warns vendor over 'life threatening' risks related to X-ray device

The mobile radiography units have reportedly been linked to two incidents—a near-miss involving a patient and a crash into an X-ray control panel. 

READ MORE >
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FDA warns vendor over 'life threatening' risks related to X-ray device

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The mobile radiography units have reportedly been linked to two incidents—a near-miss involving a patient and a crash into an X-ray control panel. 
READ MORE >

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