Next-Gen HeartMate Launches In St. Jude's Portfolio
This article was originally published in Clinica
Fresh-off bringing Thoratec Corp. into the fold, St. Jude Medical Inc. says its new left-ventricular-assist device unit has met a major regulatory milestone on schedule.
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Abbott Laboratories accounted for two of five original PMA approvals recorded by US FDA in August. That update and more from Medtech Insight's Approvals Tracker.
Abbott is issuing hardware and software updates in an attempt to resolve an issue in which patients risk injury or death when attempting to switch to a backup controller for HeartMate II left-ventricular assist devices at home.
St. Jude Medical says it will pay $3.4 billion to own ventricular-assist device leader Thoratec, pointing to significant synergies in the heart failure and interventional cardiology markets. The deal would thrust VADs into a diversified cardiology firm for the first time, and it includes a "go-shop" period that leaves an opening for other big device firms to enter competing bids.