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.   

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U.S. FDA Sign

FDA recalls surgical packs due to risk of microbial contamination

Multiple lots of ophthalmic surgery packs manufactured by Alcon will need to be disposed of, due to an incomplete seal that could cause the sterile bandages and syringes inside to be compromised. Because of the serious health risk posed to patients, this recall has been designated Class I. 

the words "FDA recall" on a board

FDA confirms new recall after catheter sheath was left in patient’s body

This is a Class I recall, which means the FDA believes these devices could cause a serious injury or death.

President Trump

Trump regrets undergoing CT to evaluate heart health—cardiologist still baffled by his aspirin use

President Trump, 79, says he is still in excellent health. He also has no intention of cutting down on the high dose of aspirin he takes each day.

M&A mergers and acquisitions business deal

W. L. Gore & Associates to acquire medtech company behind foam-based LAAO system

Conformal Medical developed its CLAAS technology to help patients with nonvalvular atrial fibrillation reduce their risk of stroke without the use of anticoagulants. Back in August, the company raised $32 million to help ramp up research on the device.

Edwards Lifesciences Sapien M3

FDA approves TMVR system from Edwards Lifesciences for high-risk heart patients

The Sapien M3 transcatheter mitral valve replacement system is implanted using a transseptal approach. The device previously received CE mark approval in 2025.

Cook Medical endovascular grafts recalled due to risk of coating breaking off, entering patient’s bloodstream.

Endovascular grafts recalled due to risk of coating breaking off, entering bloodstream

Customers are urged to examine their inventory, quarantine any unused products and return them to the manufacturer. 

heart surgery cardiac surgeons

FDA finalizes Class I recall for Medtronic catheters

There is a risk that these catheters will fail to retain their shape during use, causing procedure delays and creating the risk of an adverse outcome. The FDA first warned users about the issue back in August.

FDA recall medical device recall product recall

FDA confirms new recall for Johnson & Johnson heart device over safety concerns

Three patient deaths have been linked to connectivity issues with these devices. The FDA has classified this as a Class I recall.

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