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News You Need to Know Today
Week in Review: Device concerns put patients at risk | Mass layoffs | TAVR/PCI vs. SAVR/CABG | New AI for echo
Saturday, December 14, 2024
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This Week’s News

Industry concerns over paclitaxel-coated devices may have put PAD patients at risk

Back in 2019, the FDA issued a warning about the use of paclitaxel-coated devices when treating peripheral artery disease. The agency took back that warning in 2023, but it appears to have made a significant impact on patient care. 

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Industry concerns over paclitaxel-coated devices may have put PAD patients at risk

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Back in 2019, the FDA issued a warning about the use of paclitaxel-coated devices when treating peripheral artery disease. The agency took back that warning in 2023, but it appears to have made a significant impact on patient care. 
READ MORE >

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. 
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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 >

Heart surgeons detail world’s first robotic heart procedure of its kind

The care team behind the very first robotic aortic valve replacement and coronary artery bypass surgery has written about the experience in The Annals of Thoracic Surgery. The group discussed the development of the technique, how the patient was chosen for treatment and other key details.

READ MORE >
In October 2024, heart surgeons with the WVU Heart and Vascular Institute in Morgantown, West Virginia, performed the world’s first robotic aortic valve replacement and coronary artery bypass (RAVCAB) procedure. Now, the team behind that historic surgery has shared its full story for the first time, publishing an in-depth look at the procedure in The Annals of Thoracic Surgery, an official journal from the Society of Thoracic Surgeons. Graphic and images courtesy of Badhwar et al. and the STS.
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Heart surgeons detail world’s first robotic heart procedure of its kind

Share on Twitter Share on Facebook Share on Linkedin
In October 2024, heart surgeons with the WVU Heart and Vascular Institute in Morgantown, West Virginia, performed the world’s first robotic aortic valve replacement and coronary artery bypass (RAVCAB) procedure. Now, the team behind that historic surgery has shared its full story for the first time, publishing an in-depth look at the procedure in The Annals of Thoracic Surgery, an official journal from the Society of Thoracic Surgeons. Graphic and images courtesy of Badhwar et al. and the STS.
The care team behind the very first robotic aortic valve replacement and coronary artery bypass surgery has written about the experience in The Annals of Thoracic Surgery. The group discussed the development of the technique, how the patient was chosen for treatment and other key details.
READ MORE >

‘A significant step forward’: Advocates cheer as heart health bill passes Senate

The HEARTS Act is focused on improving cardiomyopathy education and awareness while getting more AEDs in schools. The ACC, AHA and other medical societies have supported the bipartisan bill, which now heads to the president's desk to be signed into law.

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An automated external defibrillator (AED) system installed in a public location to save patients who go into sudden cardiac arrest (sudden cardiac death).
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‘A significant step forward’: Advocates cheer as heart health bill passes Senate

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An automated external defibrillator (AED) system installed in a public location to save patients who go into sudden cardiac arrest (sudden cardiac death).
The HEARTS Act is focused on improving cardiomyopathy education and awareness while getting more AEDs in schools. The ACC, AHA and other medical societies have supported the bipartisan bill, which now heads to the president's desk to be signed into law.
READ MORE >

Years of progress have made TAVR more effective when treating concomitant mitral stenosis

Newer balloon-expandable TAVR valves are associated with much better outcomes for patients presenting with both severe AS and severe MS than older models.

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Sapien 3 Ultra Resilia TAVR valves
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Years of progress have made TAVR more effective when treating concomitant mitral stenosis

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Sapien 3 Ultra Resilia TAVR valves
Newer balloon-expandable TAVR valves are associated with much better outcomes for patients presenting with both severe AS and severe MS than older models.
READ MORE >

FDA approves J&J MedTech’s Impella heart pumps to treat pediatric patients

Johnson & Johnson MedTech partnered with the Advanced Cardiac Therapies Improving Outcomes Network to confirm these devices could safely and effectively treat younger patients. 

READ MORE >
Heart model showing biventricular hemodynamic support using the Abiomed Impella CP and the Impella RP right ventricle support device. Display from TCT 2023. Photo by Dave Fornell. Johnson & Johnson MedTech Impella
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FDA approves J&J MedTech’s Impella heart pumps to treat pediatric patients

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Heart model showing biventricular hemodynamic support using the Abiomed Impella CP and the Impella RP right ventricle support device. Display from TCT 2023. Photo by Dave Fornell. Johnson & Johnson MedTech Impella
Johnson & Johnson MedTech partnered with the Advanced Cardiac Therapies Improving Outcomes Network to confirm these devices could safely and effectively treat younger patients. 
READ MORE >

New AI program delivers rapid, accurate echo video assessments

The new technology shows early potential to make a significant impact on imaging workflows and patient care. 

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Heart AI
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New AI program delivers rapid, accurate echo video assessments

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Heart AI
The new technology shows early potential to make a significant impact on imaging workflows and patient care. 
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 >

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