Ireland-based medical device company Medtronic has reported w positive outcome from its global clinical trial of Micra Transcatheter Pacing System (TPS).
The Micra TPS is a leadless pacemaker, equal to the size of large vitamin pill.
Implanted through a minimally invasive procedure, the device is fused to the heart with small tines, it generates electrical impulses that pace the heart through an electrode located at the end of the device.
"The data showed that the risk for major complications with the Micra TPS remained consistently low, with 96% of patients experiencing no major complications through 12 months follow-up."
The Micra TPS is also fitted with a retrieval feature which enables removal when possible, however, the device is designed to stay inside the body.
It also caters to patients who need more than one device, by permanently turning off the existing device and remaining inside the body while a new device is implanted without the risk of electrical interaction.
The global clinical trial involved 644 patients who have been using the device for one year.
The data showed that the risk for major complications with the Micra TPS remained consistently low, with 96% of patients experiencing no major complications through 12 months follow-up.
The results also indicated the safety and efficacy of the device across all the groups of patients irrespective of their age, sex or comorbidity.
Medtronic senior vice-president and cardiac rhythm and heart failure division president John Liddicoat said: "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 utilisation compared to conventional pacemakers, which is promising for clinicians looking to adopt cost-effective therapies to improve patient outcomes."
Initial results of the global clinical trial released last year have also suggested the sustained safety and efficacy of the device.