Irish medical technology firm Medtronic has secured approval from the US Food and Drug Administration (FDA) for its Micra transcatheter pacing system (TPS).
Claimed to be the world’s smallest pacemaker, the Micra TPS is the first FDA-approved product with miniaturized pacing technology.
The Micra TPS is cosmetically invisible and can be delivered via a catheter and implanted directly into the heart.
Similar to the size of a large vitamin, the Micra TPS is connected to the heart with small tines and delivers electrical impulses that pace the heart through an electrode at the end of the device.
It has been approved for both 1.5 and 3 Tesla (T) full-body magnetic resonance imaging (MRI) scans, helping patients to have access to advanced imaging diagnostic procedures.
Medtronic cardiac rhythm and heart failure division president and senior vice president John Liddicoat said: "Dating back to the development of the first external battery operated pacemaker more than 60 years ago, Medtronic has a long history of collaborating with clinicians to better understand the needs of patients, and then innovating new products to meet those needs.
"We are thrilled to be the first to introduce a transcatheter pacemaker to patients in the U.S., and we’re looking forward to working with physicians and educating implanters to extend the positive results of our global clinical trial experience to even more patients."
In April 2015, the firm received CE mark approval for Micra TPS based on early data from the firm’s global clinical trial. It was approved for use in patients who need a single-chamber pacemaker.
The device was designed to enable patients to be followed by their physicians and send data remotely via the firm’s CareLink network.
Medtronic said the remote monitoring of Micra devices is expected to be available later this year.
Image: Medtronic’s Micra transcatheter pacing system. Photo: courtesy of Medtronic plc.