The US Food and Drug Administration (FDA) have granted approval for Irish medical technology firm Medtronic’s Micra transcatheter pacing system (TPS).
Claimed as the world’s smallest pacemaker for US patients, Micra TPS features miniaturised pacing technology and is the size of a large vitamin tablet.
The pacemaker is cosmetically invisible and its size allows it to be delivered through a catheter and implanted directly into the heart without requiring any cardiac wires (leads).
The Micra TPS is engrafted into the heart by small tines and issues electrical impulses that make the heart beat through an electrode at the end of the device.
The technology eliminates complications since it does not require any leads or a surgical ‘pocket’ under the skin. The device responds to patients’ activity levels by automatically adjusting therapy.
It is claimed to be the first and only transcatheter pacing system authorised to conduct both 1.5 and 3 Tesla (T) full-body magnetic resonance imaging (MRI) scans.
The equipment also features a retrieval system to be retrieved from the body whenever required.
It can also co-exist with another pacemaker by being powered off hence posing no risk of an electrical interaction.
Micra TPS Global Clinical Trial principal investigator and University of Oklahoma Health Sciences Center cardiovascular section chief Dwight Reynolds said: "In the clinical trial, the Micra was successfully implanted in nearly all patients, and met its safety and effectiveness endpoints by wide margins.
"This gives us great confidence that this miniaturised device will bring patients the most advanced pacing technology, combined with the less-invasive nature of the new technology."
The Micra trial involved 744 patients, it revealed that 96.2% of the patients had experienced no major complications while utilising the pacemaker and 98.3% of patients had low and stable heartbeat thresholds at six months, hence implying the longevity of the device will be more than 12 years.
Last year, Micra TPS was awarded CE Mark based on early data from the Medtronic Micra TPS Global Clinical Trial.
Image: Micra and traditional pacemaker. Photo: courtesy of Medtronic plc.