Micra TPS, an investigational device worldwide, has been implanted in four patients whose ages ranged from 74 to 83 years. At one month and three months, results showed that the device was successfully implanted in all patients and there were no major complications post-implant.
According to Medtronic, the device performed as expected, and electrical values were within normal ranges.
Currently, safety and efficacy of the Micra TPS is being evaluated in the company’s single-arm Micra TPS global clinical trial. The clinical trial will enroll up to 780 patients at approximately 50 centers.
Medtronic claims that Micra TPS is one-tenth the size of a conventional pacemaker and does not require a surgical incision or the creation of a pocket under the skin, which eliminates the potential source of device-related complications.
The miniature device does not require the use of leads to connect to the heart, and is attached via small tines which secure the Micra TPS to deliver electrical impulses that pace the heart.
The device is delivered directly into the heart through a catheter inserted in the femoral vein. After positioning, the pacemaker is securely attached to the heart wall and can be repositioned or retrieved if needed.
Image: Medtronic world headquarters in Minneapolis, US. Photo: Courtesy of Medtronic Inc
