MRI compatibility of PM2210

At present MRIs are being conducted on patients with PM2210s outside the USA.
It is sold as MRI compatible in the USA but does not have FDA approval for that use.

Medtronic and other companies do.
St Jude has dropped the ball here.

Comments?

2 Comments

studies

by virgilrizzo - 2014-12-11 02:12:19

http://www.mypacemaker.com/safety-information/index.htm

FDA approval

by golden_snitch - 2014-12-11 12:12:24

Hi!

I might be wrong about this, but I think you cannot sell a device as MRI compatible in the U.S. without FDA approval.

The FDA is much stricter than agencies in other countries, so it does take much longer to get the approval. I'd not say that St. Jude dropped the ball here, they are certainly waiting for FDA approval.

We have a lot more MRI compatible pacemakers on the market in the EU than you do in the U.S., because our authorities are not that strict. In Europe the companies can chose any licensing authority in any EU country, and if that authority a trial with just 30 patients is enough, then they company gets the CE mark that easily (just happened with the St. Jude Nanostim leadless pacing system).

The St. Jude Accent that you are refering to already has its CE mark (since 2011), so in Europe it is sold as an MRI compatible pacemaker. As I said, getting the CE mark is not that difficult over here - and that's not necessarily a good thing.

Inga

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