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 cardiology, heart failure, electrophysiology, hypertension, structural heart disease, use of pharmaceuticals, and COVID-19.

Update to Johnson & Johnson PFA platform gains FDA approval
The Varipulse PFA platform originally gained FDA approval in 2024. According to Johnson & Johnson MedTech, this update was put in place to help the technology provide better patient outcomes going forward.
FDA approves Bayer's finerenone to treat wide range of heart failure patients
Finerenone, sold by Bayer under the brand name Kerendia, is now approved in the United States for the treatment of HFmrEF and HFpEF. The drug has already been used for years to treat patients with chronic kidney disease and type 2 diabetes.
FDA details multiple Class I recalls for Edwards Lifesciences surgical devices
Edwards Lifesciences has recalled more than 61,000 medical devices due to the risk of a small piece of wire becoming exposed. No patient injuries have been reported at this time.
CMS proposes Medicare coverage for renal denervation
This proposal, if finalized, would dramatically increase patient access to renal denervation. Both Recor Medical and Medtronic have shared their excitement over the news.
ASE shares new recommendations for evaluating LV diastolic function, HFpEF
The new guidelines detail the use of echocardiography to evaluate patients for a variety of conditions.

$V-Wave has gained considerable attention or its Ventura Interatrial Shunt System, a small implantable device designed to reduce pressure on the left atrium and the lungs in patients with heart failure with reduced ejection fraction (HFrEF). The Ventura device includes a nitinol hourglass-shaped frame that anchors to the patient’s fossa ovalis in a way that prevents migration or embolization. It is implanted via an interventional procedure with fluoroscopy and echocardiography guidance.$

Johnson & Johnson completes V-Wave acquisition

While the initial purchase price was $600 million, the final amount could reach approximately $1.7 billion if certain milestones are met. V-Wave's VenturaInteratrial Shunt System for HFrEF has gained considerable interest in recent years, and Johnson & Johnson was an early investor in the technology back in 2016.

Ultra-high field MRI implicates long COVID in brainstem damage

Researchers have used 7T MRI to demonstrate that former COVID-19 inpatients are susceptible to persistent brainstem abnormalities associated with long-haul COVID symptoms.

artificial intelligence healthcare industry digest

ChatGPT is overly worried about ED patients

The popular AI chatbot tends to over-order X-rays, prescribe too many antibiotics and admit too many patients to the hospital when compared with a resident emergency department physician.

FDA grants AI-powered ECG screening tool for aortic stenosis its breakthrough device designation

The FDA clearly sees significant potential in this new screening software from New York-based AccurKardia.

Vaping with e-cigarettes linked to multiple cardiovascular risks

This study adds to growing evidence that e-cigarettes play a significant role in cardiovascular problems, similar to smoking. Researchers hope their work can help lead to new public health policies.

An FDA panel will discuss its recommendations related to Abbott's TriClip G4 transcatheter edge-to-edge repair (TEER) system for tricuspid regurgitation.

CMS considers Medicare coverage options for tricuspid valve repair at Abbott’s request

CMS is now accepting public comments on this topic until Nov. 2. A final decision is expected by July 2025.

The temporary rock bridge is now allowing access to the Baxter North Cove IV bag plant in North Carolina, which has enabled cleanup crews to begin work on the flooded plant that supplies 60% of U.S. IV bags.

Baxter works to get North Carolina IV plants back online as national shortages loom

Baxter's IV plant in North Carolina was flooded by Hurricane Helene. That plant provides 60% of the U.S. supply of IV bags.

The top 25 children's heart hospitals in the US

Patient outcomes, safety data and physician feedback were all used to rank the top children's hospitals for pediatric cardiology and heart surgery in the United States. Did your facility make the cut?

Clinical

Update to Johnson & Johnson PFA platform gains FDA approval

FDA approves Bayer's finerenone to treat wide range of heart failure patients

FDA details multiple Class I recalls for Edwards Lifesciences surgical devices

CMS proposes Medicare coverage for renal denervation

ASE shares new recommendations for evaluating LV diastolic function, HFpEF