The worldwide voluntary removal comes in response to reports that the pin that connects the valve to the delivery system sometimes releases prematurely, most likely due to excess tension created during manufacturing.
Boston Scientific Corp.’s Lotus transcatheter aortic valve business has run into trouble again with the company announcing a voluntary worldwide recall of all Lotus valve devices, including Lotus with Depth Guard, from all commercial and clinical sites.
The company announced Feb. 23 it was removing the devices from the field after receiving reports that the pin that...
CEO Alexandre Chau told Medtech Insight that the Middle East and Africa presented the ideal mix of market potential, physician training opportunities, and regulatory readiness when the company was considering expansion markets beyond Europe and the US.
Researchers at Johns Hopkins have used a robotic system to autonomously perform a key part of gallbladder surgery without a surgeon's hand. Lead author Axel Krieger says it could take five to 10 years before an autonomous robotic system will reach human trials and expects regulatory hurdles.
A recent approval from the US FDA allowing Boston Scientific to broaden its labeling for its pulse field ablation system means more patients with one type of AFib will have access to a promising new treatment.
