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Thousands of heart surgery kits recalled | TAVR for AR linked to 'encouraging' data | Carotid IVL | Progress for new HCM drug

News You Need to Know Today
Thousands of heart surgery kits recalled | TAVR for AR linked to 'encouraging' data | Carotid IVL | Progress for new HCM drug
Friday, June 26, 2026
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Today's News and Trends

Thousands of heart surgery kits recalled due to FDA quality concerns

Specific lots of several procedure kits have been recalled after the FDA identified quality issues during a recent inspection.

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Thousands of heart surgery kits recalled due to FDA quality concerns

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FDA recall medical device recall product recall
Specific lots of several procedure kits have been recalled after the FDA identified quality issues during a recent inspection.
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TAVR with Edwards Lifesciences valve for severe AR linked to ‘encouraging’ data

All patients presented with severe aortic regurgitation. The study's findings were presented at New York Valves 2026 and published in JSCAI.

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Performing transcatheter aortic valve replacement (TAVR) with the J-Valve transcatheter heart valve (THV) may help limit the risk of coronary artery obstruction (CAO) in high-risk patients, according to a new study published in Clinical Interventions in Aging.[1]
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TAVR with Edwards Lifesciences valve for severe AR linked to ‘encouraging’ data

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Performing transcatheter aortic valve replacement (TAVR) with the J-Valve transcatheter heart valve (THV) may help limit the risk of coronary artery obstruction (CAO) in high-risk patients, according to a new study published in Clinical Interventions in Aging.[1]
All patients presented with severe aortic regurgitation. The study's findings were presented at New York Valves 2026 and published in JSCAI.
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Shockwave Medical announces new studies evaluating carotid IVL platform

Carotid artery disease causes up to 30% of all strokes, but severely calcified lesions can make treatment quite complex. The hope is that IVL can be as successful in this area as it has been in the treatment of coronary and peripheral artery disease. 

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the SKYWARD U.S. investigational device exemption (IDE) clinical program was launched to evaluate the Shockwave SkyRunner Carotid Intravascular Lithotripsy (IVL) System to break up carotid artery calcium prior to stenting.
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Shockwave Medical announces new studies evaluating carotid IVL platform

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the SKYWARD U.S. investigational device exemption (IDE) clinical program was launched to evaluate the Shockwave SkyRunner Carotid Intravascular Lithotripsy (IVL) System to break up carotid artery calcium prior to stenting.
Carotid artery disease causes up to 30% of all strokes, but severely calcified lesions can make treatment quite complex. The hope is that IVL can be as successful in this area as it has been in the treatment of coronary and peripheral artery disease. 
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Investigational heart drug for nonobstructive HCM one step closer to FDA approval

No drugs are currently approved by the FDA for the treatment of symptomatic, nonobstructive HCM. Could oral therapy ninerafaxstat be the first?

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Investigational heart drug for nonobstructive HCM one step closer to FDA approval

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heart drugs with stethoscope
No drugs are currently approved by the FDA for the treatment of symptomatic, nonobstructive HCM. Could oral therapy ninerafaxstat be the first?
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Featured Articles

AI company founded by cardiologist gains FDA clearance, raises $8.5M

“We have colonoscopies, we have mammograms, but we have not had equivalents for most forms of heart disease,”  Pierre Elias, MD, Pathway Labs founder and CEO, explained.

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robot reviewing heart data
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AI company founded by cardiologist gains FDA clearance, raises $8.5M

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robot reviewing heart data
“We have colonoscopies, we have mammograms, but we have not had equivalents for most forms of heart disease,”  Pierre Elias, MD, Pathway Labs founder and CEO, explained.
READ MORE >

Chest pain drug lowers risk of kidney injury after PCI

Treating certain high-risk PCI patients with nicorandil before and after treatment can significantly reduce their risk of contrast-related injuries.

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Chest pain drug lowers risk of kidney injury after PCI

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Treating certain high-risk PCI patients with nicorandil before and after treatment can significantly reduce their risk of contrast-related injuries.
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New digital platform gets clinicians on the same page when treating heart attacks

One of the platform's biggest benefits is the rich clinical information it provides to all members of the care team.

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 Derek Pineda, FNP, CCRN, RCIS, FACC, with Mount Sinai Fuster Heart Hospital, explains the use of a digital app platform for STEMI team coordination that helped his health system improve STEMI outcomes.
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New digital platform gets clinicians on the same page when treating heart attacks

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 Derek Pineda, FNP, CCRN, RCIS, FACC, with Mount Sinai Fuster Heart Hospital, explains the use of a digital app platform for STEMI team coordination that helped his health system improve STEMI outcomes.
One of the platform's biggest benefits is the rich clinical information it provides to all members of the care team.
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In Case You Missed It

What every cardiologist should consider before signing a contract

Cathie Biga, MSN, a former ACC president, says salary is just one thing a cardiologist should ask about before signing any contract.

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Cathie Biga, MSM, MACC, past president of the American College of Cardiology (ACC) and president/CEO of Cardiovascular Management of Illinois, explains some of the key consideration and strategic questions cardiologists should ask before signing a contract.
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What every cardiologist should consider before signing a contract

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Cathie Biga, MSM, MACC, past president of the American College of Cardiology (ACC) and president/CEO of Cardiovascular Management of Illinois, explains some of the key consideration and strategic questions cardiologists should ask before signing a contract.
Cathie Biga, MSN, a former ACC president, says salary is just one thing a cardiologist should ask about before signing any contract.
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FDA shares another warning about Impella heart pumps after death

The FDA is once again warning the public about a safety issue with certain Impella heart pumps. 

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Impella CP Johnson & Johnson MedTech Abiomed
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FDA shares another warning about Impella heart pumps after death

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Impella CP Johnson & Johnson MedTech Abiomed
The FDA is once again warning the public about a safety issue with certain Impella heart pumps. 
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FDA sees potential in new AI software for monitoring heart failure patients

The software-only platform helps clinicians keep track of patients when they are at their most vulnerable.

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The Cardiac Performance Simulation Engine (CPSE) is an AI platform that enables consumer-grade smartwatches and blood pressure cuffs for remote home monitoring hemodynamic assessments of heart failure patients.
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FDA sees potential in new AI software for monitoring heart failure patients

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The Cardiac Performance Simulation Engine (CPSE) is an AI platform that enables consumer-grade smartwatches and blood pressure cuffs for remote home monitoring hemodynamic assessments of heart failure patients.
The software-only platform helps clinicians keep track of patients when they are at their most vulnerable.
READ MORE >

In Other News

CMS projection: 90% of Americans will still have health insurance in 2034—when healthcare spending reaches $9T

Legislative changes, demographic shifts and growing demand will combine to drive national health spending to almost $9 trillion by 2034.

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Economics
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CMS projection: 90% of Americans will still have health insurance in 2034—when healthcare spending reaches $9T

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Economics
Legislative changes, demographic shifts and growing demand will combine to drive national health spending to almost $9 trillion by 2034.
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Kaiser Permanente to pay community hospital over $82M to resolve out-of-network reimbursement dispute

The lawsuit dates back to 2019 but has been stuck in the court process for years. In the end, the health plan will pay Pomona Valley Hospital for emergency care delivered to patients at an out-of-network rate—though the facility didn’t get all of what it was seeking. 

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the-kaiser-permanente-thrive-center-street-telegraph_1300x867.jpg
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Kaiser Permanente to pay community hospital over $82M to resolve out-of-network reimbursement dispute

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the-kaiser-permanente-thrive-center-street-telegraph_1300x867.jpg
The lawsuit dates back to 2019 but has been stuck in the court process for years. In the end, the health plan will pay Pomona Valley Hospital for emergency care delivered to patients at an out-of-network rate—though the facility didn’t get all of what it was seeking. 
READ MORE >

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