Global Device Approvals, Weekly Snapshot: Medtronic, Edwards Wins In Europe
A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. CE marks for a Medtronic stent graft and Edwards Lifesciences' TAVR update anchor this week's list.
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Edwards Lifesciences plans a "controlled rollout" of its Sapien 3 Ultra transcatheter heart valve replacement in Europe following the CE mark announced Nov. 16. But a patent dispute with Boston Scientific will prevent Edwards from launching it in Germany.
A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. Among the additions, Abbott's HeartMate 3 left ventricular assist device gained "destination therapy" approval from US FDA, meaning its now vetted for use in patients who are not eligible for a heart transplant.
The company is sponsoring the first clinical study of robotically assisted electromagnetic-guided percutaneous access and mini-percutaneous nephrolithotomy – kidney stone removal – with the Monarch robotic-assisted platform for urology.