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.

FDA warns that certain sizing catheters should not be used due to risk of breaking
These catheters from Cook Medical are associated with an increased risk of device fragmentation or vessel injury. Customers are urged to return them to the manufacturer.
Medline recalls millions of devices due to safety risk—FDA threatens ‘regulatory action’ in warning letter
Millions of angiographic syringes were recalled due to a risk of parts becoming loose or disconnected. The FDA, unhappy with Medline's response to this situation, sent the company a new warning letter.
Mount Sinai announces new global center focused on heart valve disease
The Adams Valve Institute—named after David H. Adams, MD—plans on uniting specialists to provide high-quality care, promote innovation and advocate for policy reform.
New gene therapy may help protect the hearts of patients with Friedreich's ataxia
A majority of deaths from Friedreich's ataxia are associated with heart complications. A new treatment years in the making could provide some much-needed relief.
Insurance industry boasts 11% reduction in prior authorizations since 2025 reform rollout
That equates to eliminating 6.5 million prior authorization barriers. The results come from a survey of major health plans conducted by AHIP and the Blue Cross Blue Shield Association.

Beacon Tip Centimeter Sizing Catheter FDA alert

FDA warns that certain sizing catheters should not be used due to risk of breaking

These catheters from Cook Medical are associated with an increased risk of device fragmentation or vessel injury. Customers are urged to return them to the manufacturer.

warning safety alert recall healthcare issue

Medline recalls millions of devices due to safety risk—FDA threatens ‘regulatory action’ in warning letter

Millions of angiographic syringes were recalled due to a risk of parts becoming loose or disconnected. The FDA, unhappy with Medline's response to this situation, sent the company a new warning letter.

The leaders of the new Adams Valve Institute at Mount Sinai are Ismail El-Hamamsy, MD, PhD, director of aortic surgery and director of the Adams Valve Institute (left), and David H. Adams, MD, the Marie-Josée and Henry R. Kravis Professor and chair of the Department of Cardiovascular Surgery at the Icahn School of Medicine, and cardiac surgeon-in-chief of the Mount Sinai Health System.

Mount Sinai announces new global center focused on heart valve disease

The Adams Valve Institute—named after David H. Adams, MD—plans on uniting specialists to provide high-quality care, promote innovation and advocate for policy reform.

Video interview with Ronald Crystal, MD, chair, Department of Genetic Medicine at Weill Cornell Medicine, presented late-breaking findings on a first in-human, virus-delivered gene therapy trial to stop cardiomyopathy death in patients with Friedreich Ataxia (FA). #ACC #ACC26

New gene therapy may help protect the hearts of patients with Friedreich's ataxia

A majority of deaths from Friedreich's ataxia are associated with heart complications. A new treatment years in the making could provide some much-needed relief.

Insurance industry boasts 11% reduction in prior authorizations since 2025 reform rollout

That equates to eliminating 6.5 million prior authorization barriers. The results come from a survey of major health plans conducted by AHIP and the Blue Cross Blue Shield Association.

Prem Soman, MD, director of the Cardiac Amyloidosis Center and nuclear cardiology, and associate chief of cardiology at the University of Pittsburgh Medical Center Heart and Vascular Institute presented the late-breaking results from the long-term survival benefits and disease stabilization with the drug acoramidis in patients with transthyretin amyloid cardiomyopathy at ACC 2026.

Long-term cardiac amyloidosis survival benefits seen in extension acoramidis trial

Patient outcomes clearly show acoramidis reduces both all-cause mortality and cardiovascular hospitalizations, but the study also reinforced the importance of early diagnosis and prompt medical therapy.

Johnson & Johnson announced the launch of its new Varipulse Pro pulsed field ablation (PFA) system in Europe following CE mark approval. It is five times faster at ablation delivery at a cooler temperature than the previous version.

Johnson & Johnson launches faster PFA system in Europe

The new version of the PFA system is five times faster than the current catheter to improve workflow.

The U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) to conduct a pivotal clinical trial for TRiCares Topaz transcatheter tricuspid valve replacement (TTVR) system in the U.S. The TTVR system uses two stent frames, one for the valve and one to engage the annulus with a membrane shirt between them to enable flexing of the outer ring to better seal against regurgitation.expansing stents

FDA clears way for IDE pivotal trial of the Topaz tricuspid valve replacement system

The TRiCares Topaz uses a unique two-stent frame valve prosthesis for better sealing and flexibility.