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News You Need to Know Today
TAVR & PCI vs. SAVR & CABG | First device of its kind granted key FDA exemption | Depression impacts TAVR outcomes
Tuesday, December 10, 2024
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Today's News and Trends

TAVR/PCI bests SAVR/CABG when treating severe AS and complex CAD

Percutaneous treatment was linked to improved survival and fewer adverse events than surgery when patients presented with both symptomatic severe aortic stenosis and complex coronary artery disease. 

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2024 has been a banner year for structural heart treatments, especially those focused on the tricuspid valve. In February, for example, Edwards Lifesciences made history when its Evoque transcatheter tricuspid valve replacement (TTVR) system became the first device of its kind to gain U.S. Food and Drug Administration (FDA) approval for treating tricuspid regurgitation (TR). Two months later, Abbott’s TriClip transcatheter edge-to-edge repair (TEER) system also gained FDA approval for the treatment of TR.
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TAVR/PCI bests SAVR/CABG when treating severe AS and complex CAD

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2024 has been a banner year for structural heart treatments, especially those focused on the tricuspid valve. In February, for example, Edwards Lifesciences made history when its Evoque transcatheter tricuspid valve replacement (TTVR) system became the first device of its kind to gain U.S. Food and Drug Administration (FDA) approval for treating tricuspid regurgitation (TR). Two months later, Abbott’s TriClip transcatheter edge-to-edge repair (TEER) system also gained FDA approval for the treatment of TR.
Percutaneous treatment was linked to improved survival and fewer adverse events than surgery when patients presented with both symptomatic severe aortic stenosis and complex coronary artery disease. 
READ MORE >

First surgical device of its kind granted key FDA exemption

This update helps ensure Artivion's AMDS Hybrid Prosthesis can be used to treat high-risk patients as the FDA makes its final approval decision. The news came as Artivion works to bounce back from a cybersecurity attack that occurred in November.

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Artivion, an Atlanta-based medical device company, has received a Humanitarian Device Exemption (HDE) from the U.S. Food and Drug Administration (FDA) for its AMDS Hybrid Prosthesis designed to treat DeBakey Type 1 dissections when malperfusion occurs. This HDE ensures select patients can be treated with the device before the FDA makes its final approval decision.
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First surgical device of its kind granted key FDA exemption

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Artivion, an Atlanta-based medical device company, has received a Humanitarian Device Exemption (HDE) from the U.S. Food and Drug Administration (FDA) for its AMDS Hybrid Prosthesis designed to treat DeBakey Type 1 dissections when malperfusion occurs. This HDE ensures select patients can be treated with the device before the FDA makes its final approval decision.
This update helps ensure Artivion's AMDS Hybrid Prosthesis can be used to treat high-risk patients as the FDA makes its final approval decision. The news came as Artivion works to bounce back from a cybersecurity attack that occurred in November.
READ MORE >

TAVR survival less likely when patients are depressed

Screening TAVR patients for signs of depression prior to treatment could help providers adapt as necessary and deliver better patient care.

READ MORE >
USPSTF updates its stance on aspirin use to prevent CVD, sees no benefit for patients 60 or older.
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TAVR survival less likely when patients are depressed

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USPSTF updates its stance on aspirin use to prevent CVD, sees no benefit for patients 60 or older.
Screening TAVR patients for signs of depression prior to treatment could help providers adapt as necessary and deliver better patient care.
READ MORE >

Featured Articles

Medical device company cuts 70% of staff in push to meet Medtronic obligations

California-based Acutus Medical has said its ongoing agreement to manufacture and distribute left-heart access devices for Medtronic is the company's only source of revenue. 

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Acutus Medical, the California-based healthcare technology company focused on electrophysiology devices, has announced significant downsizing that will cut its workforce by approximately 70%. The goal of the move is to focus exclusively on manufacturing and distributing left-heart access devices as part of a distribution deal with Medtronic that was first signed in 2022.
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Medical device company cuts 70% of staff in push to meet Medtronic obligations

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Acutus Medical, the California-based healthcare technology company focused on electrophysiology devices, has announced significant downsizing that will cut its workforce by approximately 70%. The goal of the move is to focus exclusively on manufacturing and distributing left-heart access devices as part of a distribution deal with Medtronic that was first signed in 2022.
California-based Acutus Medical has said its ongoing agreement to manufacture and distribute left-heart access devices for Medtronic is the company's only source of revenue. 
READ MORE >

Insulet wins $452M in lawsuit against rivals over medical device trade secrets

Insulet accused multiple parties, including a rival CEO, of working together to copy its insulin pump technology and bring a "clone product" to market.

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statue justice legal verdict malpractice case lawsuit scale
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Insulet wins $452M in lawsuit against rivals over medical device trade secrets

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statue justice legal verdict malpractice case lawsuit scale
Insulet accused multiple parties, including a rival CEO, of working together to copy its insulin pump technology and bring a "clone product" to market.
READ MORE >

More vulnerable, but still treatable: Frail heart patients benefit from PCI, CABG

High-risk patients are often treated with medical therapy alone instead of revascularization. However, new data make it clear that these patients can live much longer when treated with PCI or CABG.

READ MORE >
With advances and increased experience in the percutaneous coronary intervention (PCI), same-day discharge (SDD) has become increasingly commonplace, but patient selection is key. Antithrombotic therapy may not be necessary for certain transcatheter aortic valve replacement (TAVR) patients, according to a new analysis published in JACC: Cardiovascular Interventions.
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More vulnerable, but still treatable: Frail heart patients benefit from PCI, CABG

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With advances and increased experience in the percutaneous coronary intervention (PCI), same-day discharge (SDD) has become increasingly commonplace, but patient selection is key. Antithrombotic therapy may not be necessary for certain transcatheter aortic valve replacement (TAVR) patients, according to a new analysis published in JACC: Cardiovascular Interventions.
High-risk patients are often treated with medical therapy alone instead of revascularization. However, new data make it clear that these patients can live much longer when treated with PCI or CABG.
READ MORE >

In Case You Missed It

First patients treated with Abbott’s new balloon-expandable TAVR valve

Abbott already has an FDA-approved self-expanding TAVR valve, the Navitor system, on the market. The company is now evaluating the safety and effectiveness of a new balloon-expandable device that could potentially be implanted using software guidance. 

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Cardiologist Azeem Latib
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First patients treated with Abbott’s new balloon-expandable TAVR valve

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Cardiologist Azeem Latib
Abbott already has an FDA-approved self-expanding TAVR valve, the Navitor system, on the market. The company is now evaluating the safety and effectiveness of a new balloon-expandable device that could potentially be implanted using software guidance. 
READ MORE >

How to overcome imaging challenges during tricuspid valve procedures

Gilbert Tang, MD, surgical director of the structural heart program at the Mount Sinai Health System, discussed a key challenge care teams often encounter during tricuspid valve procedures. 

READ MORE >
Gilbert H. Tang, MD, professor in the Department of Cardiovascular Surgery at the Icahn School of Medicine and surgical director of the Structural Heart Program at the Mount Sinai Health System, explains how to overcome the limited imaging windows of the tricupid valve using a TEE and intracardiac echo (ICE) at TCT 2024.
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How to overcome imaging challenges during tricuspid valve procedures

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Gilbert H. Tang, MD, professor in the Department of Cardiovascular Surgery at the Icahn School of Medicine and surgical director of the Structural Heart Program at the Mount Sinai Health System, explains how to overcome the limited imaging windows of the tricupid valve using a TEE and intracardiac echo (ICE) at TCT 2024.
Gilbert Tang, MD, surgical director of the structural heart program at the Mount Sinai Health System, discussed a key challenge care teams often encounter during tricuspid valve procedures. 
READ MORE >

Contrast injections during angiography, PCI unlikely to cause coronary injuries

The pressure changes associated with contrast injections are minimal, researchers noted, especially once you move away from the tip of the catheter. 

READ MORE >
Interventional cardiologists performing PCI
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Contrast injections during angiography, PCI unlikely to cause coronary injuries

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Interventional cardiologists performing PCI
The pressure changes associated with contrast injections are minimal, researchers noted, especially once you move away from the tip of the catheter. 
READ MORE >

In Other News

Suspect in murder of UnitedHealthcare CEO arrested in Pennsylvania

Luigi Mangione, 26, was on a Greyhound bus traveling through the area on Monday morning. When he stopped at a McDonald's, an employee recognized him from photos circulated by the NYPD. Mangione had evidence on his person linking him to the crime, police said.

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UnitedHealthcare CEO Shooter NYPD Crime Stoppers
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Suspect in murder of UnitedHealthcare CEO arrested in Pennsylvania

Share on Twitter Share on Facebook Share on Linkedin
UnitedHealthcare CEO Shooter NYPD Crime Stoppers
Luigi Mangione, 26, was on a Greyhound bus traveling through the area on Monday morning. When he stopped at a McDonald's, an employee recognized him from photos circulated by the NYPD. Mangione had evidence on his person linking him to the crime, police said.
READ MORE >

Key takeaways from RSNA 2024 for AI, CT, MRI and the radiology staffing shortage

Several key trends were evident at the Radiological Society of North America 2024 meeting, including new CT and MR technology and evolving adoption of artificial intelligence.

READ MORE >
RSNA attendees through bore of the new release Philips CT 5300 scanner at RSNA 2024. Three new CT systems were released at RSNA that included numerous AI enhancements. Photo by Dave Fornell. #RSNA #RSNA24 #RSNA2024
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Key takeaways from RSNA 2024 for AI, CT, MRI and the radiology staffing shortage

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RSNA attendees through bore of the new release Philips CT 5300 scanner at RSNA 2024. Three new CT systems were released at RSNA that included numerous AI enhancements. Photo by Dave Fornell. #RSNA #RSNA24 #RSNA2024
Several key trends were evident at the Radiological Society of North America 2024 meeting, including new CT and MR technology and evolving adoption of artificial intelligence.
READ MORE >

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