Positive data for Micra Transcatheter Pacing System presented at EHRA EUROPACE-CARDIOSTIM meeting- Medtronic

Medtronic plc reported study results of its Micra Transcatheter Pacing System (TPS) at a late-breaking clinical trials session at EHRA EUROPACE-CARDIOSTIM 2015 in Milan. The study results demonstrated that the miniaturized pacemaker met initial safety and performance measures in its global clinical trial. Of the first 140 patients who received the Micra TPS, 100 percent were successfully implanted. At one- and three-month follow ups, all patients had mean electrical pacing measurements within expected ranges. The first 140 patients in the Medtronic Micra TPS Global Clinical Trial were implanted by 37 physicians at 23 sites across Asia-Pacific, Europe and the United States. They spanned a wide variety of patient profiles such as age (from 21 to 94 years), weight (ranging from 41 to 148 kilograms), and residence (including Asia-Pacific, Europe and the U.S.). Patients considered to be at high risk also participated in the study, including patients with lung disease such as COPD (chronic obstructive pulmonary disease) and pulmonary hypertension.

Of the 140 patients followed for an average of 1.9 months, eight patients experienced a serious adverse event and most of these were easily managed; only two patients (1.4 percent) experienced events which resulted in prolonged hospitalization. This rate is in line with rates observed in studies of traditional pacemakers. Importantly, there were no infections or dislodgments, and no events required surgical re-operation or resulted in death. Further, there were no (0) unanticipated serious adverse device events (assumed <5 percent. testing of electrical performance at three months showed the pacing threshold was lower 0.51v at 0.24ms than the pre-specified performance objective><2.0v at 0.24ms resulting in an expected average longevity of at least 10 years.>

These initial results from the clinical trial also were published in the European Heart Journal, Early performance of a miniaturized leadless cardiac pacemaker: the Micra Transcatheter Pacing Study.

Comment: At less than one-tenth the size of traditional pacemakers, the Micra TPS provides the most advanced pacing technology available while being cosmetically invisible and small enough to be delivered with minimally invasive techniques through a catheter, and implanted directly into the heart. The small size and short length of the Micra device allows physicians to implant more than one device within the heart, if needed.

See- European Heart Journal, doi:10.1093/eurheartj/ehv214.