Medtronic PLC scored an industry first this month with U.S. approval to start selling its leadless pacemaker, Micra, which represents the first entry in what may become a new class of slender, minimally invasive pacemakers that rest entirely inside the heart.
But if these new pacemakers are going to revolutionize the business of keeping hearts in rhythm, they will have to be perceived as safe.
That's why Medtronic has developed a rigorous training program for doctors who want to implant its vitamin-pill-sized device. The Minnesota-designed Micra attaches to the inner heart wall directly, avoiding the need for insulated wires called leads to deliver the pacemaker's electric pulses. Leads have been called the "Achilles' heel" of pacemakers because they can wear out and create infection risk.
Leadless pacers, implanted inside the heart's right ventricle, are expected to grow into a $700 million global market in coming years, analysts estimate. That tally may grow exponentially as the devices grow in complexity to pace two or even three chambers of the heart, instead of just one. Less than a quarter of pacemakers sold today are so-called single-chamber devices.
This month, Medtronic's single-chamber Micra became the first leadless pacemaker to get U.S. Food and Drug Administration approval, following a global clinical trial that found a consistent safety record and a paucity of bad outcomes.
Company officials say those results likely flow, at least in part, from a multistage training program used to familiarize doctors in the study with how to properly implant a new type of medical device. Medtronic is now preparing to roll out the same training system across the country.
"It was a pretty robust training. And I think that is part of the reason" why none of the 725 Micra devices implanted during the trial became dislodged in the heart, said Dr. Robert Kowal, a Dallas electrophysiologist who put in about 15 of the devices during the company-sponsored, nonrandomized clinical trial.
Kowal and other new implanters received on-site training using a cadaver and implanting in animals. Medtronic officials said training for most new implanters may include simulators, video explanations and other methods, either at a Medtronic facility or at the hospital. The initial implanter at a hospital trains others by letting them first observe cases, then "scrubbing in" with the experienced doctor for five cases, and finally doing the procedure themselves under observation.