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.

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.
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.

Left atrial appendage occlusion (LAAO) with the Watchman FLX device from Boston Scientific is associated with positive outcomes and limited adverse events after one year, according to new findings published in Circulation: Cardiovascular Interventions.[1] Many prior Watchman FLX studies, including PINNACLE FLX, had focused on the device’s performance in a controlled setting. The study’s authors hoped to gain a better understanding of its real-world impact by reviewing registry data from more than 97,000 U.S

LAAO with Watchman FLX associated with positive 1-year outcomes, real-world data confirm

Researchers hoped to gain a better understanding of the device's real-world impact by reviewing registry data from more than 97,000 U.S. patients. Overall, the Watchman FLX was linked to positive data and limited adverse events one year after treatment.

FDA approves epinephrine nasal spray for anaphylaxis

The Neffy nasal spray was shown to be as effective as injectables in four studies on 175 adults.

Study calls for MRI follow-up in concussion patients

Follow-up MRI in patients with mild traumatic brain injuries could help predict if they will experience lingering symptoms months later, even if their initial imaging was normal.

physician tracking patient data and reporting on outcomes

Cardiology groups introduce new performance, quality measures for heart failure

The American College of Cardiology, American Heart Association and Heart Failure Society of America worked together on the updated document, adding three new performance measures and six new quality measures. They did not remove a single recommendation from the previous document published in 2020.

The J-Valve manufactured by JC Medical, a Genesis MedTech company, includes a self-expanding nitinol frame, bovine pericardial leaflets and three anchor rings designed to assist operators with alignment. Its delivery system was built with transfemoral access in mind, and JC Medical plans to offer the valve in five different sizes.

New TAVR valve for native aortic regurgitation linked to positive 30-day outcomes

The J Valve from JC Medical was linked to positive outcomes and “excellent” hemodynamic data after 30 days in an early feasibility study published in JACC: Cardiovascular Interventions. Researchers noted that the valve showed potential in patients with large aortic annuli, which represents an "unmet critical need" at this stage.

Newsweek ranked the 50 best heart hospitals in the world

10 key updates from new American College of Cardiology inpatient heart failure recommendations

The new expert consensus decision pathway replaces a similar document from 2019 and is to be used in conjunction with heart failure guidelines published in 2022 by the ACC, American Heart Association and Heart Failure Society of America.

Novo Nordisk withdraws FDA application to expand use of weight loss drug

The Danish pharmaceutical company said it will resubmit its application in 2025 to have Wegovy approved for use in heart failure patients.

Huxley Medical, an Atlanta-based medical device company, has secured U.S. Food and Drug Administration (FDA) clearance for its new Sansa device, a chest-worn patch designed to help diagnose sleep apnea in addition to tracking patient data with electrocardiograms (ECGs) a variety of sensors.

FDA clears chest-worn patch for simultaneous ECG, sleep apnea monitoring

The new device from Huxley Medical offers care teams a way to monitor patients for signs of sleep apnea while also keeping a close eye on their heart health.

Clinical

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

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

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