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.   

the words "FDA recall" on a board

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.

CorWave LVAD

World’s first patient receives new-look heart pump—cardiologist ‘impressed’ by device’s performance

The CorWave technology is unlike other left ventricular assist devices, working in harmony with the patient's heartbeat and making adjustments as needed. 

FDA issues Class I recall on infant heated wire circuits prone to disconnect

The faulty adapters must not be used. The devices, manufactured under the brand name AirLife, must be identified and quarantined because of the high risk of severe injury or death associated with the malfunction.

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Statin use may protect patients from subarachnoid hemorrhages

Statins appear to be the most impactful for patients diagnosed with hypertension or cerebrovascular disease.

aktiia hilo band cuffless blood pressure monitor

‘The start of a paradigm shift’: FDA clears first over-the-counter cuffless blood pressure monitor

The cuffless technology, which has already gained CE mark approval, should make its U.S. debut in 2026.

old woman or doctor shaking hands with patient

Early occlusion after CABG much more likely for female patients

Care teams should be aware of this difference, even using CT images when possible to look for signs of any potential issues.