News & Announcements Discontinuation of the Abbott Microny Pacemaker

Discontinuation of the Abbott Microny Pacemaker

October 25, 2017
Dear Fellow PACES EP Colleagues,

It has been recently announced that Abbott (previously St Jude) was forced to discontinue production of the Microny Pacemaker due to the obsolescence of components required to manufacturer more devices. For years this device has been the smallest pacemaker on the market at 5.9 cc, and has been an essential option for the smallest of children who require pacing, particularly premature infants, as the next smallest device is 30% larger than the Microny.

There are currently approximately 100 devices in the United States, with expiration dates between now and the spring of 2019 (18 months, or 67 per year on an annualized basis).  There is no equivalent device anticipated in the near future.  Based on a sampling of usage in North America over the last ten years, approximately 40 devices per year were implanted in infants under 10 days of age, 50 in those under a month, and 75 in those under three months.   The vast majority of these infants were small for gestational age or premature, most with weights below 4.5 kg, many far below. Due to the impact of this issue on pediatric electrophysiologists, the PACES executive felt it was important to be proactive. The current usage data would suggest that if devices are only used in children weighing < 4.5 kg the current inventory would allow enough devices for our premature infants and the current supply should get us close to the time of a potentially new device. PACES is working with Abbott to be certain that the devices with the shortest expiration dates are implanted first. We would encourage all pediatric electrophysiologists to use the devices they think are most appropriate. If there is equal justification between a Microny and an alternative device, then a non-Microny device should be considered so as to prolong the inventory of remaining devices.  

Given the fact that implantation of such devices is often performed in conjunction with a pediatric cardiac surgeon this information is being shared with surgeons via the Congenital Heart Surgeons’ Society. In addition, we would encourage all pediatric electrophysiologists to work with their fetal teams and Abbott if they are aware of an impending delivery of a neonate with AV block.  I want to personally thank Beth Stephenson, Anne Dubin, and Yaniv Bar-Cohen who have been instrumental in facilitating discussions with Abbott and coming up with some structured recommendations for PACES regarding the discontinuation of the Microny pacemaker.  We hope that everyone will work together so that the current remaining devices are used for the most appropriate candidates until a newer device becomes available. If you have specific questions please feel free to reach out to me.

Sincerely,
Mitchell I.  Cohen, MD FACC FHRS                                                    
President, Pediatric & Congenital Electrophysiology Society                  mitchcohenmd@gmail.com