Ireland-based Medtronic has announced that its Micra Transcatheter Pacing System (TPS) met initial safety and performance standards in its global clinical trial.
According to the study results, which were announced at EHRA EUROPACE-CARDIOSTIM 2015, 100% of the initially tested 140 patients underwent successful implant procedure for the miniature pacemaker.
Mean electrical pacing measurements for all the patients were within expected ranges, at one- and three-month follow ups.
University Hospital of Bordeaux cardiologist and Micra TPS Global Clinical Trial principal investigator Philippe Ritter said: "The initial results for this novel device are quite promising, and similar to results seen with conventional pacemakers.
"Patients in this study have fared very well, and if the strong safety and performance profile of the Micra TPS continues with more patients and over the long-term, this transcatheter pacing therapy will prove to be a simpler, less-invasive pacemaker option while maintaining therapy effectiveness."
Initial 140 patients, who were subjected to the trial, included profiles with varieties in age, weight, residence and risks. About 37 physicians carried on the implantation process at 23 sites across Asia-Pacific, Europe and the US.
Micra TPS, which was commercially launched in Europe earlier in the month, is less than one-tenth the size of conventionally used pacemakers.
Being cosmetically invisible, it enables physicians to make more than one implants within the heart, through minimally invasive operations, if required.
It does not require wires, or ‘leads’, to deliver the pacing therapy and can be repositioned or retrieved, when needed. It is also equipped with automatic adjusting features, which allow the device to respond to patients’ activity levels on its own during the therapy.
Micra TPS, however, is still an investigational device in the US and has not been approved for commercial usage.
Image: Operational headquarters of Medtronic at Fridley in Minnesota,US. Photo: courtesy of Bobak Ha’Eri / Wikipedia.