Abbott's Amplatzer Paraclose PVL Occluder is the first heart device of its kind approved by the FDA to treat paravalvular leak. The agency made its decision after reviewing data from 200 patients who had undergone aortic or mitral valve replacement surgery.

In terms of the study's primary endpoint, using CCTA to guide procedures was noninferior to IVUS. CCTA was also linked to certain advantages over IVUS, including improved cath lab efficiency. 

The real-world benefits of renal denervation were a hot topic at TCT 2026 in San Diego.

The Shockwave C2 Aero Fly Coronary IVL Catheter from Johnson & Johnson MedTech is now available. In addition, the company announced, the next-generation device will be featured in its booth at TCT 2026. 

Clinicians have been using this device to perform M-TEER for years. After this latest announcement, it is now officially approved for both mitral valve repair and tricuspid valve repair.

The FDA previously warned that certain Impella heart pump controllers may need hardware, firmware and/or software updates. The agency has now categorized the issue as a Class I recall. The devices should be removed from where they are used or sold until they can be serviced, but they can still be used if necessary to ensure patients receive care.

Cardiac arrest still occurs during nearly 1% of all PCI procedures. It is most common during acute coronary syndrome interventions.

Certain Sapien M3 TMVR delivery systems have been linked to a risk of malfunctioning in a way that puts patients at risk. The devices included in this early alert should be returned to the manufacturer. 

The Freesolve Resorbable Magnesium Scaffold previously received the same designation for below-the-knee interventions. This update covers minimally invasive coronary procedures.

Survey data will be used in advocacy efforts with employers and policymakers to advance key safety initiatives.