“World’s Smallest Pacemaker” Experiences Sizeable Success

TitleMedtronic recently announced continued success with what it describes as “the world’s smallest pacemaker.”  The Micra® Transcatheter Pacing System (TPS) is less than one-tenth of the size of traditional pacemakers (examples of each type of pacemaker, both produced by Medtronic, are shown to the left).  Medtronic states that the device provides select patients suffering from bradycardia with a minimally invasive treatment approach.

The Micra TPS, which is comparable in size to a large vitamin (as seen to the right), attaches to the heart with small tines and delivers electrical impulses that pace the heart.  Thanks to its size and wireless technology, the Micra TPS does not require
leads under the patient’s skin.  As such, the Micra TPS eliminates potential sources of complications that may be associated with more traditional pacemakers.  Artist’s renderings comparing the Micra TPS and a traditional pacemaker when implanted are shown below.

Following what Medtronic describes as “the largest and longest clinical evaluation of leadless pacing patients to date,” the company released several statistics from its Micra TPS Global Clinical Trial that highlight the device’s long-term successes, including:

  • 96% freedom-from-complication rate
  • When compared to traditional pacemaker systems, the risk of
    • major complications was reduced by 48% across all patient subgroups including age, gender and comorbidity
    • hospitalization was lowered by 47%, and
    • revision procedures was 82% lower
  • The battery is projected to last an average of 12 years, based on data from 644 patients who have had the device for at least 12 months.

Regarding these results, John Liddicoat, M.D., senior vice president at Medtronic, stated:

The Micra TPS continues to deliver safe and effective pacing, while also providing a less invasive alternative to conventional pacemakers . . . .  The Micra TPS has also shown a significant reduction in healthcare utilization compared to conventional pacemakers, which is promising for clinicians looking to adopt cost-effective therapies to improve patient outcomes.

These statistics follow preliminary results published in the New England Journal of Medicine in November 2015, showing that the Micra TPS was successfully implanted in 99.2% of patients. Medtronic interprets the studies as demonstrating consistent and sustained results from early performance through 12-month follow-up.

Dr. John Hummel, a cardiologist who participated in the clinical trials, explains his view that Medtronic’s wireless pacing technology is the future of pacemaker therapy.

We are looking at the beginning of the future . . . .  We will no longer pace the heart in the way we have in the last 20 to 30 years.  This is fundamentally a paradigm shift in how we’ll deliver this therapy.

The Micra TPS was awarded its CE Mark in April 2015.  Additionally, the device was approved by the FDA for use in the United States in April 2016.  The device is presently the only leadless pacemaker approved for use in both the United States and Europe.

 

Albert Sueiras
Albert Sueiras is an associate in the Orange County office. Mr. Sueiras received his bachelor's degree in Biomedical Engineering, cum laude, from the University of Miami and also received his master's degree in Biomedical Engineering, cum laude, from the University of Florida. He received his J.D. from the University of Florida Levin College of Law, where he was a member of Phi Delta Phi. During law school, Mr. Sueiras externed at the United States Patent and Trademark Office within Art Unit 3733, focusing on patent examination of orthopedic surgical instrumentation. Mr. Sueiras also participated in a patent prosecution externship at Banyan Biomarkers, Inc. in Alachua, Florida, a firm specializing in the discovery of biomarkers for traumatic brain injury and neurotoxicity. Mr. Sueiras worked as a summer associate at the firm in 2015 and joined the firm in 2016.
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