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Week in Review: New valve used for TMVR, TTVR on same patient | Medtronic & Abbott unite | Novartis sues FDA

News You Need to Know Today
Week in Review: New valve used for TMVR, TTVR on same patient | Medtronic & Abbott unite | Novartis sues FDA
Saturday, August 10, 2024
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This Week’s News

Cardiologists first in world to use new heart valve for TMVR, TTVR on same patient

Identical Cardiovalve systems were used to perform the procedures 18 months apart on a high-risk heart patient. 

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Cardiovalve heart valve transfemoral TMVR TTVR
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Cardiologists first in world to use new heart valve for TMVR, TTVR on same patient

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Cardiovalve heart valve transfemoral TMVR TTVR
Identical Cardiovalve systems were used to perform the procedures 18 months apart on a high-risk heart patient. 
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First-generation Medtronic TAVR valves linked to strong outcomes after 12 years

Researchers tracked the long-term safety, effectiveness and durability of first-generation CoreValve devices in nearly 900 patients.

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Medtronic CoreValve TAVR first-generation transcatheter heart valve
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First-generation Medtronic TAVR valves linked to strong outcomes after 12 years

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Medtronic CoreValve TAVR first-generation transcatheter heart valve
Researchers tracked the long-term safety, effectiveness and durability of first-generation CoreValve devices in nearly 900 patients.
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Medtronic and Abbott join forces to develop new diabetes tech

Medtronic and Abbott are often seen as rivals in a competitive marketplace, but the two companies are collaborating with a simple goal in mind: improving patient access to high-quality CGM devices. 

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handshake
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Medtronic and Abbott join forces to develop new diabetes tech

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handshake
Medtronic and Abbott are often seen as rivals in a competitive marketplace, but the two companies are collaborating with a simple goal in mind: improving patient access to high-quality CGM devices. 
READ MORE >

Novartis sues FDA over ‘unlawful’ approval of generic heart failure drug

The drugmaker argues that the FDA's recent approval of a generic version of Entresto should not be allowed for multiple reasons. Novartis sent multiple requests to the agency hoping to stop the approval, but the FDA denied each one. 

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The long legal saga of Richard Paulus, a Kentucky cardiologist accused of performing unnecessary cardiac procedures, appears to still be going strong in 2022 and might be reviewed by the Supreme Court. The New York state radiologist is facing 36 misdemeanor counts for secret sexual recording without consent, according to a story in the Boston Herald.
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Novartis sues FDA over ‘unlawful’ approval of generic heart failure drug

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The long legal saga of Richard Paulus, a Kentucky cardiologist accused of performing unnecessary cardiac procedures, appears to still be going strong in 2022 and might be reviewed by the Supreme Court. The New York state radiologist is facing 36 misdemeanor counts for secret sexual recording without consent, according to a story in the Boston Herald.
The drugmaker argues that the FDA's recent approval of a generic version of Entresto should not be allowed for multiple reasons. Novartis sent multiple requests to the agency hoping to stop the approval, but the FDA denied each one. 
READ MORE >

Cerebral protection during TAVR linked to lower risk of major stroke, other key benefits

Using a cerebral protection device during TAVR was associated with lower readmission rates, shorter hospital stays—and, yes, a lower risk of patients suffering a major stroke. A team of specialists with Cleveland Clinic shared their new findings in the Journal of the American Heart Association.

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Boston Scientific's Sentinel Cerebral Protection System during a TAVR procedure prevents emboli released from going to the brain and causing a stroke.
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Cerebral protection during TAVR linked to lower risk of major stroke, other key benefits

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Boston Scientific's Sentinel Cerebral Protection System during a TAVR procedure prevents emboli released from going to the brain and causing a stroke.
Using a cerebral protection device during TAVR was associated with lower readmission rates, shorter hospital stays—and, yes, a lower risk of patients suffering a major stroke. A team of specialists with Cleveland Clinic shared their new findings in the Journal of the American Heart Association.
READ MORE >

What cardiologists should expect as U.S. healthcare payment models evolve

Cardiologist Dan Blumenthal, MD, MBA, explains how changes in Medicare payments will greatly impact cardiology in the years ahead. In just a few short years, the business side of cardiology could look substantially different than it does today. 

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Dan Blumenthal, MD, MBA, chief quality officer at the Cardiovascular Associates of America, and a cardiologist at Massachusetts General Hospital, spoke at the Heart Rhythm Society (HRS) 2024 meeting business sessions on how changes in Medicare payments will impact electrophysiology and cardiology more broadly.
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What cardiologists should expect as U.S. healthcare payment models evolve

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Dan Blumenthal, MD, MBA, chief quality officer at the Cardiovascular Associates of America, and a cardiologist at Massachusetts General Hospital, spoke at the Heart Rhythm Society (HRS) 2024 meeting business sessions on how changes in Medicare payments will impact electrophysiology and cardiology more broadly.
Cardiologist Dan Blumenthal, MD, MBA, explains how changes in Medicare payments will greatly impact cardiology in the years ahead. In just a few short years, the business side of cardiology could look substantially different than it does today. 
READ MORE >

FDA sees potential in new PET imaging agent for cardiac amyloidosis

Early evidence suggests a new PET imaging agent from California-based Attralus can help evaluate all varieties of systemic cardiac amyloidosis. It has now been granted the FDA's breakthrough therapy designation. 

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doctor examines patient data on their tablet
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FDA sees potential in new PET imaging agent for cardiac amyloidosis

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doctor examines patient data on their tablet
Early evidence suggests a new PET imaging agent from California-based Attralus can help evaluate all varieties of systemic cardiac amyloidosis. It has now been granted the FDA's breakthrough therapy designation. 
READ MORE >

10 key updates from new American College of Cardiology inpatient heart failure recommendations

The new expert consensus decision pathway replaces a similar document from 2019 and is to be used in conjunction with heart failure guidelines published in 2022 by the ACC, American Heart Association and Heart Failure Society of America.

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Newsweek ranked the 50 best heart hospitals in the world
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10 key updates from new American College of Cardiology inpatient heart failure recommendations

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Newsweek ranked the 50 best heart hospitals in the world
The new expert consensus decision pathway replaces a similar document from 2019 and is to be used in conjunction with heart failure guidelines published in 2022 by the ACC, American Heart Association and Heart Failure Society of America.
READ MORE >

FDA clears chest-worn patch for simultaneous ECG, sleep apnea monitoring

The new device from Huxley Medical offers care teams a way to monitor patients for signs of sleep apnea while also keeping a close eye on their heart health. 

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Huxley Medical, an Atlanta-based medical device company, has secured U.S. Food and Drug Administration (FDA) clearance for its new Sansa device, a chest-worn patch designed to help diagnose sleep apnea in addition to tracking patient data with electrocardiograms (ECGs) and a variety of sensors.
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FDA clears chest-worn patch for simultaneous ECG, sleep apnea monitoring

Share on Twitter Share on Facebook Share on Linkedin
Huxley Medical, an Atlanta-based medical device company, has secured U.S. Food and Drug Administration (FDA) clearance for its new Sansa device, a chest-worn patch designed to help diagnose sleep apnea in addition to tracking patient data with electrocardiograms (ECGs) and a variety of sensors.
The new device from Huxley Medical offers care teams a way to monitor patients for signs of sleep apnea while also keeping a close eye on their heart health. 
READ MORE >

CMS increases inpatient payment for implantable Barostim device

CVRx has now received improved outpatient and inpatient reimbursements for its implantable heart failure device in the last 12 months. The company's president says these updates will help more patients gain access to the Barostim technology. 

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CVRx Barostim illustration
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CMS increases inpatient payment for implantable Barostim device

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CVRx Barostim illustration
CVRx has now received improved outpatient and inpatient reimbursements for its implantable heart failure device in the last 12 months. The company's president says these updates will help more patients gain access to the Barostim technology. 
READ MORE >

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