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.

The late-breaking U.S. multicenter admIRE clinical trial at the Heart Rhythm Society 2024 meeting, showed positive data on the long-term safety and effectiveness of the the Biosense Webster Varipulse pulsed field ablation (PFA) system in patients with paroxysmal atrial fibrillation. #HRS #HRS2024 #PFA

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.

Bayer finerenone Kerendia heart failure MOONRAKER

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.

The Medtronic Symplicity Spyral Renal Denervation system uses a catheter that curls in the renal artery to place radiofrequency electrodes against the vessel wall to ablate the nerves that control vasodilation, so the artery can be propped in the fully open position.

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.

Sanitation issue forces FDA recall of ventilator suction systems

Ballard Closed Suction Systems will need to be returned to the manufacturer for a refund due to the high risk of a potentially fatal infection stemming from their use.

The balloon-expandable Myval transcatheter aortic valve replacement (TAVR) valve is associated with positive real-world data after four years.

Myval TAVR valve associated with positive durability data after 4 years

Researchers have been spending more and more time evaluating the Myval TAVR valve from Indian medtech company Meril Life Sciences. The balloon-expandable device is available in some parts of the world, but not the United States.

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

Medicare now covers TriClip procedures for patients with symptomatic tricuspid regurgitation

CMS has finalized a new national coverage determination for T-TEER, sometimes known as transcatheter tricuspid valve repair. Abbott's TriClip is the only device approved by the FDA for T-TEER, but other treatment options are under development.