Medtronic has announced that its Micra transcatheter pacing system (TPS) has been implanted in the first patient in the US, as part of the company's single-arm, multi-centre global clinical trial.
It was successfully implanted at NYU Langone Medical Center by Dr Larry Chinitz, director of the Heart Rhythm Center at NYU Langone Medical Center in New York City.
"Eliminating the need for a lead and pocket has the potential to reduce complications and recovery times compared to traditional pacemaker implants, which would be a major benefit to patients," Dr Chinitz said.
The trial will enrol around 780 patients at approximately 50 centres and initial results from the first 60 patients, followed up to three months, are expected to be released in the second half of 2014.
The pacing system is just one-tenth the size of a conventional pacemaker and is comparable in dimensions to a large vitamin.
Micra TPS, claimed to be the world's smallest pacemaker, can be directly introduced into the heart through a minimally invasive procedure without the need for leads to connect to the heart.
It 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 if required.
Attached to the heart through small tines, the Micra TPS delivers electrical impulses that pace the heart through an electrode at the end of the device.
The Micra TPS implant imparts several benefits compared to the current pacemaker implant procedures.
Micra TPS being very small in size does not require the creation of a 'pocket' under the skin, so does not display any visible sign of the device.
In addition, it does not require a surgical incision in the chest thereby eliminating a potential source of device-related complications.
Medtronic cardiac rhythm disease management business president Pat Mackin: "Less invasive, miniature device technologies show strong promise in improving patient outcomes and implant procedure efficiency."
"The FDA's interactive review with CRDM was a key part of the IDE application approval process, and through our global Micra TPS clinical trial, we intend to generate robust evidence of these benefits to patients and clinicians throughout the world."
Image: Medtronic enrols first us patient in global clinical trial for miniature transcatheter pacemaker system. Photo: courtesy of Medtronic, Inc.