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.

FDA recalls pediatric breathing kits after eight serious injuries

Endotracheal tubes inside Medline neonatal intubation kits have been deemed too narrow, putting newborn patients at risk for hypoxia. This recall has been given the most serious FDA designation due to the risk of death.

Janet Wei, MD, Erika J. Glazer Chair in Women’s Cardiovascular Research, Education and Innovation at the Smidt Heart Institute at Cedars-Sinai Hospital, explains the key differences between men and women in cardiovascular disease presentations and disease progression. She said heart disease its the number one cause of death in women and the guidelines cannot be a one size fits all document lumping men and women together, they really need to separate out specific details for women.

Cardiology societies should develop separate guidelines for treating female heart patients

Janet Wei, MD, examined the key differences between men and women when it comes to cardiovascular disease. These differences, she said, highlight why female patients need their very own treatment guidelines.

Atraverse Medical raises $29M to support FDA-approved heart tech

The San Diego-based startup gained FDA approval for its Hotwire RF guidewire in 2024. The technology has already been used to perform hundreds of heart procedures.

Statue of Liberty New York City healthcare

Late-breaking clinical trials announced for New York Valves 2025

The three-day event is now in its second year. Each day will feature late-breaking clinical trials focused on a different heart valve.

Eli Lilly to acquire gene-editing specialists focused on CVD for up to $1.3B

The company has agreed to acquire Verve Therapeutics for an upfront payment of approximately $1 billion. The total could increase significantly, however, if certain milestones are met. One of Verve's biggest gene therapies has already received the FDA's fast track designation.

FDA recalls Zyno infusion pumps, citing risk of death

Some infusion systems manufactured by Zyno Medical were released with unapproved software that could cause safety features to malfunction. Use of any device subject to the recall is to cease immediately.

Why more doctors should pursue business and leadership training

“Just as medicine has its own language, so does business," two surgeons explained in a new editorial.

Inquis Medical Aventus Thrombectomy System

FDA clears blood clot removal system for treating pulmonary embolism

The Aventus Thrombectomy System was already cleared to treat blood clots in the peripheral arteries. This latest approval comes after positive results from an IDE study were published in JSCAI.

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