Irish medical technology firm Medtronic has reported the results of its Micra Transcatheter Pacing System (TPS) clinical trial.
According to the company, the Micra TPS global clinical trial demonstrated that the miniaturized pacemaker has reached its initial safety and performance measures.
University Hospital of Bordeaux cardiologist and Micra TPS global clinical trial principal investigator Dr Philippe Ritter said: "If the strong safety and performance profile of the Micra TPS that we’ve seen so far persists over the long-term and in more patients, this transcatheter pacing therapy will prove to be an effective but simpler and less-invasive pacemaker option for many patients."
The trial’s first enrolled 140 patients at 23 sites across Asia-Pacific, Europe and the US experienced a successful implant procedure and mean electrical pacing measurements at all patient visits were within expected ranges, said the firm.
It included high-risk patients with lung disease such as chronic obstructive pulmonary disease (COPD) and pulmonary hypertension.
In April of this year, the Micra TPS received CE mark approval based on the data from the Medtronic Micra TPS global clinical trial and is claimed to be the first system to receive CE mark for 1.5T and 3T full body MRI scanning.
Medtronic noted that the trial is ongoing and will continue to assess safety and efficacy of the device through a single-arm, multi-center study that has enrolled more than 700 patients at 56 centers in 19 countries.
The Micra TPS is an investigational device and not yet approved for commercial use in the US.