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FDA recall medical device recall product recall

Specific lots of several procedure kits have been recalled after the FDA identified quality issues during a recent inspection.

the SKYWARD U.S. investigational device exemption (IDE) clinical program was launched to evaluate the Shockwave SkyRunner Carotid Intravascular Lithotripsy (IVL) System to break up carotid artery calcium prior to stenting.

Carotid artery disease causes up to 30% of all strokes, but severely calcified lesions can make treatment quite complex. The hope is that IVL can be as successful in this area as it has been in the treatment of coronary and peripheral artery disease. 

Performing transcatheter aortic valve replacement (TAVR) with the J-Valve transcatheter heart valve (THV) may help limit the risk of coronary artery obstruction (CAO) in high-risk patients, according to a new study published in Clinical Interventions in Aging.[1]

All patients presented with severe aortic regurgitation. The study's findings were presented at New York Valves 2026 and published in JSCAI.

heart drugs with stethoscope

No drugs are currently approved by the FDA for the treatment of symptomatic, nonobstructive HCM. Could oral therapy ninerafaxstat be the first?

Treating certain high-risk PCI patients with nicorandil before and after treatment can significantly reduce their risk of contrast-related injuries.

robot reviewing heart data

“We have colonoscopies, we have mammograms, but we have not had equivalents for most forms of heart disease,”  Pierre Elias, MD, Pathway Labs founder and CEO, explained.

Innovation at work

Follow-up care after a successful heart transplant can be challenging—both for providers and their patients. Consider, for example, the fact that so many patients who develop complications never actually present with symptoms.  

In cooperation with CareDx