Clinical

This channel newsfeed includes clinical content on treating patients or the clinical implications in a variety of cardiac subspecialties and disease states. The channel includes news on cardiac surgery, interventional cardiologyheart failure, electrophysiologyhypertension, structural heart disease, use of pharmaceuticals, and COVID-19.   

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.

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.

Non-enhancing asymmetries on contrast-enhanced mammography

Is additional imaging necessary for non-enhancing asymmetries on contrast-enhanced mammograms?

Patients with asymmetries on CEM typically are recalled for additional views, ultrasound and occasionally MRI. But the extra workup might not be necessary.

Cardiologist heart

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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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.

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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.

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.

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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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.

Anthem

Anthem BCBS reverses course on anesthesia time limits

After announcing it would place time limits on reimbursement for the time a patient is under anesthesia, Anthem Blue Cross Blue Shield has now denied it ever intended to make the change.