New leaderless vs traditional PM

I have had a symptomless form of Afib for 6 years and my heart heat will take a 2-3 second break a few hundred times a day. Recently I passed out so the cardiologist recommended a PM. When I went for a second opinion, I was told I was a good candidate to go into a trial for the new St Jude leadless PM. While only in the trial stage in the US, I understand this has been approved in several European countries. Have others looked into the leaderless PM verse the traditional? Which did you choose and why?
I just found this site yesterday. Looks like a great site.

2 Comments

Leadless pacing

by golden_snitch - 2015-04-26 02:04:23

Both leadless devices, the St. Jude Nanostim and the Medtronic Micra TPS, have already got their CE mark, so they are approved in the European Union. Don't ask how, though. In the case of the St. Jude device, they got approval with a study of just 30 patients of whom one or two died due to perforation of the ventricular wall. Some more complications happened with the St. Jude device, so that some of the clinics which were part of the trial, refused to continue with implants. Medtronic got approval with a study of 60 patients. I have heard nothing negative about their leadless device, yet.

In my opinion it was WAY too early to give those products a CE mark, but unfortunately the whole approval process here for medical technology is not as strict as the FDA's.

There are a couple of members in this club who have the Medtronic Micra TPS. Haven't heard from anyone with the St. Jude Nanostim, yet.

do your homework

by Tracey_E - 2015-04-27 05:04:07

Leadless technology is super exciting! Leads are probably the single biggest long term downside to being paced. However, I don't know that I'd want to be an experiment for something as important as my heart, jmho. Aside from the fact that there isn't long term research yet and very few test cases, there are also very limited places they can be maintained. Someone posted a month or so ago who had one, I can't remember if it was Micra or Nanostim, but the person moved and was told he had to travel back to the original hospital to be treated. His local dr was unfamiliar with them and unable to provide follow up care.

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