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.

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.
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.
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.

Report: Medicaid cuts could force hundreds of rural hospitals to close their doors

A report from the Chartis Center for Rural Health warns that many hospitals in rural communities are at risk of closure if Medicaid cuts pass through Congress and are enacted by President Donald Trump. According to the analysis, women and newborns will disproportionately lose access to care.

FDA issues Class I recall on GE Carestations due to ventilation issue

The issue stems from a mode on the ventilation systems malfunctioning. Although no devices need to be removed from care settings, some will require repair.

FDA issues emergency recall on resuscitation systems due to failure code

A specific model of AutoPulse resuscitation system manufactured by Zoll is prone to a failure code that could result in inadequate chest compressions being administered to patients. The affected kits must be removed from the supply chain immediately.

Ancora Heart AccuCinch Ventricular Restoration System heart failure FDA

First 250 patients enrolled in transcatheter heart failure device trial to reduce LV size

The first 250 patients has been enrolled in the CORCINCH-HF U.S. pivotal trial evaluating the AccuCinch Transcatheter Left Ventricular Restoration System in patients with HFrEF.

FDA declares Class I recall on heart surgery procedure kits from Medline

The news is related to an earlier recall of more than 316,000 Medtronic devices.

A majority of medical devices involved in Class I recalls were never required by the U.S. Food and Drug Administration (FDA) to undergo premarket or postmarket clinical testing, according to new research published in Annals of Internal Medicine.[1]

American College of Cardiology now supports early use of medication to treat obesity

The group highlighted the proven effectiveness of these drugs, especially semaglutide and tirzepatide, while noting that eligibility, affordability and availability will still play key roles in any treatment decisions.

Papers discussing ‘gender’ have been restored to government website

The information was deleted to comply with an executive order from President Trump that censored content related to “gender ideology.” However, a federal judge has ordered the content restored as a court battle looms.

Cook Medical angiographic catheter recall

Angiographic catheters recalled due to safety risk

The new Class I recall includes nearly 27,000 devices that could potentially experience a harmful defect during use.

Clinical

CMS proposes Medicare coverage for renal denervation

ASE shares new recommendations for evaluating LV diastolic function, HFpEF

Sanitation issue forces FDA recall of ventilator suction systems

Myval TAVR valve associated with positive durability data after 4 years

Medicare now covers TriClip procedures for patients with symptomatic tricuspid regurgitation