The device does not require invasive surgery to be implanted
A miniaturised, wireless
pacemaker that can be inserted into the body without invasive surgery
has been given approval for use in the European Union.
Developed by US start-up Nanostim, the device is designed to be implanted intravenously directly in the heart.
It is less than 10% of the size of a conventional pacemaker and uses a built-in battery.
Experts said it was an "exciting development" but at a very early stage.
The pacemaker has yet to receive full US Food and Drug Administration (FDA) approval.
Conventional pacemakers require a patient to be cut open and a
pocket created in the body to house the pacemaker and associated wires.
Such wires are regarded as the component of pacemakers most
likely to fail. The pocket created for the pacemaker is also liable to
By contrast the Nanostim pacemaker is delivered via a catheter inserted through the femoral vein near the groin.
It has a built-in battery, smaller than an AAA battery, that
lasts between nine and 13 years. Eliminating the need for wires lowers
the risk of infection or malfunction and means that patients are not
restricted in the amount of activity they do, the firm behind the device
The procedure to fit the pacemaker typically lasts around
half an hour. The device is designed to be easily retrievable so that
the battery can be replaced.
Because the device is delivered intravenously, it also means patients will have no scarring.
One doctor, involved in its trials, described it as "the future of pacemaking".
"For the past 40 years the therapeutic promise of leadless
pacing has been discussed, but until now, no-one has been able to
overcome the technical challenges," said Dr Johannes Sperzel of the
Kerchhoff Klinik in Bad Nauheim, Germany.
"This revolutionary technology offers patients a safe,
minimally-invasive option for pacemaker delivery that eliminates leads
and surgical pockets," he added.
But others were more cautious.
Prof Jeremy Pearson, associate medical director at the
British Heart Foundation, said: "This is a potentially exciting
development but it's early days.
"Before this leadless pacemaker becomes widely available, we
need a better understanding of how long it will last, as well as how
easy it is to replace if necessary. As our knowledge of this new
pacemaker widens, so too will the expertise needed to fit this
potentially exciting device."
The company behind the device has recently been bought by global medical device firm St Jude.
It has had several wire-based pacemakers recalled in recent years.
Other device makers are also planning to go wireless. The
Wireless Cardiac Stimulation system has been developed by US start-up
EBR Systems and UK-based tech firm Cambridge Consultants and uses a tiny
wireless electrode no bigger than a grain of rice powered by an
ultrasonic pulse generator, inserted lower down in the chest.
In 2011 the device was implanted in 100 patients in hospitals across Europe.
Cardiac pacemakers are used to treat slow heart rates. The
devices monitor the heart and provide electrical stimulation when the
heart beats too slowly.
The first pacemaker was fitted in 1958. Currently more than
four million people around the world have some sort of cardiac rhythm
device with an additional 700,000 people getting one each year.