At the end of January, the Micra AV was approved for use in the United States by the FDA. This Medtronic device has significantly changed the technology behind pacemakers by adding small enhancements to the original Micra’s design. The AV’s main benefit when compared to the original Micra is the ability to handle dual-chamber pacing systems that the initial model could not (Newmarker, 2020). As a result, the Micra AV will be able to help a larger number of patients than its predecessor. 

When hospitals’ value analysis committees (VACs) compare the Micra AV to the original Micra and other pacemakers, they will see that the AV is a much more comprehensive product. The updated version is still the same size and shape as the previous, but the competitive advantage is that it detects cardiac movement. The AV will also remain leadless like the original, meaning there won’t be wires running throughout the heart (Newmarker, 2020). This continuation is significant as it will greatly reduce the number of patient complications experienced while using the device. According to CathLabDigest, the most important difference between the two versions is that the updated adaptation will be capable of helping those with an AV block, hence the new name (CathLabDigest, 2020). There is no doubt that VACs will be getting a better deal and a more effective product when they decide to purchase the Micra AV. Healthcare organizations can also expect their patient outcomes to improve with the new version. 

The newfound ability to treat AV blocks with a leadless device is groundbreaking in the medical field. It was previously only possible with dual chamber pacing systems, but will now be feasible with the Micra AV. According to a previous study completed using the original Micra, patients can expect a 63% reduction in major complications as a result of the device (Garweg et al., 2019). If the results of this study could be generalized to the population that needs dual chamber pacing systems, the AV would be able to provide better care to a new and large group of people. They would also be significantly more likely to avoid complications and stay healthy.

This new version of the Micra will be instrumental in changing many people’s lives. According to Chris Newmarker’s list, “The 10 Greatest Medtech Advances of the 2010s,” the Micra already ranked seventh for its innovation (Newmarker, 2020). Since the Micra AV will be an improvement upon its predecessor and increase the number of individuals that can be helped, the impact it will have on the healthcare community is evident. 

The bottom line is that the new Micra AV will be able to help more people than the original model.  Hospital VACs now have a new product to evaluate before agreeing to purchase, or enter an agreement with a GPO based on the device. Value Analysis Committee members and Supply Chain Managers will soon see this product being requested by physicians. Through GreenLight, this product has already been requested by 14 physicians at eight facilities.

 

If you would like to learn more about value analysis process or request a demo, please click here.

 

Resources:

FDA Approves Medtronic Micra AV, the World’s Smallest Pacemaker Which Can Now Treat AV Block. (2020, January 21). Retrieved from https://www.cathlabdigest.com/content/fda-approves-medtronic-micra-av-worlds-smallest-pacemaker-which-can-now-treat-av-block

Garweg, C., Splett, V., Sheldon, T. J., Chinitz, L., Ritter, P., Steinwender, C., … Willems, R. (2019). Behavior of leadless AV synchronous pacing during atrial arrhythmias and stability of the atrial signals over time – results of the MARVEL Evolve subanalysis. Pacing and Clinical Electrophysiology, 42(3), 381–387. doi: 10.1111/pace.13616

Newmarker, C. (2020, January 21). BREAKING: Medtronic wins FDA approval for Micra AV. Retrieved from https://www.massdevice.com/breaking-medpaptronic-wins-fda-approval-for-micra-av/

Newmarker, C. (2020, January 2). A host of the greatest medtech advances of the 2010s. Retrieved from https://www.medicaldesignandoutsourcing.com/the-10-greatest-medtech-advances-of-the-2010s/5/

Photo Source: https://www.med-technews.com/news/medtronic-receives-clearance-for-small-av-pacemaker/