Leadless

Does anyone know anyone who has received the new leadless pacemaker units by Nanostim.. This is a company that St Jude purchased .. The pacemaker itself is about the size of a coin. At the moment they are not available in the U.S. but are in use in Europe

3 Comments

Nanostim

by golden_snitch - 2014-11-27 08:11:11

Hi!

Implants have been performed in Germany, but have been stopped now because the complication and mortality rate is much higher than in conventional pacemakers. This is not due to the Nanostim not functioning, but due to the whole implant procedure. Apparently, the screw at the tip of the device has perforated the right ventricle in several cases. In Germany two people died, in the EU all together, I think, six deaths have been reported and some more pericardial effusions due to perforation of the ventricle. St. Jude only handed in a study with 30 patients - of whom one died - to get the CE mark (equivalent to FDA approval in the US), and unfortunately the certification agency gave them the CE mark. In my opinion, it's a shame that they got the CE mark with such little data on the device. There is no data about removing the device in humans, this has only been tested in animals so far.

Not sure what's going to happen next, but I am quite sure that this device will not receive FDA approval for a long time. And within the EU I hope that the CE mark will be withdrawn from St. Jude.

Inga

Leadless

by valmet - 2014-11-27 09:11:45

Thanks Inga Valuable information. All the Best for the Holidays

Bob

I have the Micra TPS

by Runningmama - 2014-11-27 12:11:12

I had the Medtronic version of the Leadless pacemaker, the TPS installed almost three weeks ago.

You know you're wired when...

You have a 25 year mortgage on your device.

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