Medtronic has unveiled new positive data for its Micra Transcatheter Pacing System (TPS) from the Micra Coverage with Evidence Development (CED) study.
The Micra CED study is an ongoing, continuously enrolling, observational, cohort study evaluating claims-based complications, utilisation and outcomes of Micra TPS in the US.
In the study, researchers evaluated 6,219 patients implanted with Micra VR TPS and 10,212 patients implanted with traditional TV-VVI pacemakers.
The Micra CED trial compared system reinterventions, chronic complications, and all-cause mortality two years after the implant.
In the study, Micra TPS has resulted in a reduction in reinterventions by 38% and a reduction in chronic complications by 31% in two years, compared to transvenous (TV-VVI) pacemakers.
Also, patients implanted with Micra TPS had higher rates of end-stage renal disease (ESRD) and renal dysfunction, and a higher Charlson Comorbidity Index score than TV-VVI patients.
Medtronic claimed that Micra CED is the largest study of leadless pacemakers to date.
Also, it is the first study to use Centres for Medicare & Medicaid Services (CMS) claims data to evaluate leadless pacing, compared to patients implanted with TV-VVI pacemakers.
About Micra Transcatheter Pacing System (TPS)
Micra TPS is a leadless pacemaker option, designed for patients who require pacing only in their right ventricle, with a size less than one-tenth of the traditional pacemakers.
It delivers a minimally invasive approach, and it does not need the leads or a surgical pocket under the skin, eliminating potential sources of complications related to them.
The device attaches to the heart with small tines and delivers electrical impulses that pace the heart through an electrode at the end of the device.
Medtronic has secured the CE Mark approval for the Micra TPS system in 2015 and has received US FDA approval in 2016.
Medtronic Cardiac Rhythm Management business chief medical officer Rob Kowal said: “As part of our commitment to improving outcomes for patients needing pacing therapy, we embraced the opportunity to evaluate our devices in a real-world setting.
“The results presented at ESC further reinforce the significant advantages of leadless pacemakers and support earlier findings that show a reduced risk of complications with Micra TPS. These data should assist physicians and patients to select the most appropriate, individualised pacing option to meet their goals.”
