Medtronic’s Micra pacemakers are one-tenth the size of what was previously out there. How the medtech giant did it provides lessons for anyone looking to shrink an implantable device.It was an all-hands-on-deck effort that consumed Medtronic in the early 2010s: the in-house creation of a pacemaker small enough to go inside the heart via a catheter.
The tiny pacemaker could be a game-changer because it would do away with connecting wires to the heart — a major source of complications. To get there, though, the Medtronic development team had to solve significant challenges involving battery life and energy use. How could they create a pacemaker that was roughly one-tenth the size of a traditional pacemaker but still last at least seven years inside someone?
“It would be like taking your car and reducing the size of the tank by a factor of 10 — and now asking this same car to go the same amount of distance,” Leonardo Rapallini told Medical Design & Outsourcing in a recent interview. Now VP of R&D for Medtronic’s cardiac diagnostics and services business, Rapallini was the Micra effort’s senior program director for nearly five years.
Rapallini and his colleagues solved the challenge — and more as they boosted device longevity to 12 years for many patients. FDA initially approved the Micra in 2016. Last year, it approved the next-gen Micra AV that uses additional internal atrial sensing algorithms to provide therapies associated with dual-chamber pacing systems. During a May earnings call, CEO Geoff Martha announced that Micra has quickly grown into a $400-million-a-year business.