Medtronic Enters Leadless Pacemaker Competition With Micra CE Mark
This article was originally published in The Gray Sheet
The firm’s ultra-small leadless pacing system has been cleared to launch in Europe, where it will face off with St. Jude’s Nanostim, which is slowly recovering from a pause in implants in 2014.
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The firm announced the first U.S. implant for its investigational Micra transcatheter, leadless pacing system, and the global launch of its miniature Reveal LINQ implantable cardiac monitor.
St. Jude paid $123.5 million and agreed to up to $65 million in additional milestone payments to acquire Nanostim and its first-in-class leadless pacemaker, which has just earned a CE mark and is expected to launch in select European markets soon.
The US FDA has overhauled its ‘Purple Book’ to make it a searchable database of biologics information. The agency is also seeking input on next steps.