Boston Scientific announced it has received FDA approval for the LOTUS Edge Aortic Valve System. Delivered via a “minimally-invasive procedure”, this transcatheter aortic valve replacement technology is approved for patients with severe aortic stenosis who are considered at high risk for surgical valve replacement via open heart surgery. The company commenced a controlled launch of the valve system in Europe in March and expects to begin a controlled launch in the U.S. in the coming weeks.
https://thefly.com/landingPageNews.php?id=2896133
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