Preliminary results from the first four human procedures with the Micra Transcatheter Pacing System (Medtronic) have shown the device has been successfully implanted with no major complications post-implant.
Results were presented by Clemens Steinwender, head of cardiology at the Linz General Hospital in Linz, Austria, at Cardiostim/EHRA Europace (18–21 June, Nice, France).
Steinwender told delegates that at one month and three months the device has been implanted successfully in four patients (74 to 83 years old), no major complications (after implant) were reported and the device has performed as expected. He also said that electrical values were within normal ranges.
“We are encouraged by these preliminary results and are hopeful that this less invasive procedure will provide similar outcomes for all patients in the trial,” said Steinwender.
The first in-human implant of Micra was announced on 9 December.
The Micra TPS is an investigational device worldwide and not approved in the USA. It is currently being evaluated in the Medtronic Micra Transcatheter Pacing System (TPS) Global Clinical Trial. The Trial is a single-arm, multicentre study that will enrol up to 780 patients at approximately 50 centres.
Micra does not require a surgical incision or the creation of a pocket under the skin, which eliminates any visible sign of the device and a potential source of device-related complications. At one-tenth the size of a conventional pacemaker, and comparable in size to a large vitamin, Micra is delivered directly into the heart through a catheter inserted in the femoral vein. Once positioned, the pacemaker is securely attached to the heart wall and can be repositioned or retrieved if needed. The device does not require the use of leads and is attached via small tines to secure it to the heart wall.