European Union Approves Nanostim Wireless Pacemaker

First Posted: Oct 15, 2013 03:20 PM EDT
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The European Union has recently approved the use of a tiny and wireless pacemaker device. This highly advanced tool does not require invasive surgery that typically goes along with the implantation of a pacemaker, as it is small enough to be intravenously inserted directly into the heart.

The new device was created by the startup group Nanostim from the United States and is smaller than the conventional pacemaker by 10 percent. It's also charged by a built in battery. The way the tiny pacemaker is implanted works through a catheter that is inserted into the femoral vein located in the groin. The built in battery is smaller than a AAA battery and can last anywhere from nine to 13 years. Fittings for the device take less than an hour and no scarring is involved, according to the Food and Drug Administration (FDA).

The current process for receiving a pacemaker can be somewhat of a difficult and timely procedure. For instance, patients must undergo surgery that requires doctors to cut a pocket for the device. This not only creates more down time in order for the patient to heal, but it can also increase the risks of infection. And if the device is installed incorrectly, it is more difficult to remove and re-install.

"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. Sperzel was one of the doctors involved in the trials, according to the BBC. "This revolutionary technology offers patients a safe, minimally-invasive option for pacemaker delivery that eliminates leads and surgical pockets."

Yet despite the potentials of this new device, some health professionals are skeptical as the technological tool is in its early stages.

"This is a potentially exciting development but it's early days," Professor Jeremy Pearson, associate medical director at the British Heart Foundation, said via the news organization. "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."

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