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

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

Healthcare policies have rapidly evolved in recent years, and 2025 was no exception. From payment policies to physician shortages, ASE and other medical societies had plenty to fight for throughout the year.

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.

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

Make way for MiniMed! Medtronic's diabetes division has filed the necessary paperwork to go public. The company hopes to be traded on Nasdaq under the symbol MMED.

"If you're not using an intravascular imaging modality, the PCI is not optimal," explained Haroon Faraz, MD, from Hackensack University Medical Center. Faraz is hopeful new and improved technologies will help these modalities become more popular among interventional cardiologists.

AstraZeneca has stopped selling Andexxa because randomized data suggested some patients may face an increased risk of certain adverse events. The company emphasized that it remains confident in the agent's abilities.

The Volt Pulsed Field Ablation System from Abbott has been approved by the FDA. The technology, which gained CE mark approval in March, features a one-of-a-kind catheter design and allows patients to be treated under conscious sedation.

Cytokinetics has secured FDA approval for aficamten, its new drug for the treatment of symptomatic obstructive HCM. Aficamten will be sold under the brand name Myqorzo.