Medical Monitoring & Remote Programming: Biotronik Eluna Pacemaker System Given FDA Approval for MRI Full Body Scans

Friday, March 20, 2015

Biotronik Eluna Pacemaker System Given FDA Approval for MRI Full Body Scans

A brief note ... the FDA has given approval the patients implanted with the Biotronik Eluna pacemaker can safely undergo full MRI body scans. Note, this approval does NOT say that this pacemaker is MRI-safe. Someone implanted with this pacemaker cannot be placed in an MRI without making the necessary changes.

The pacemaker is MRI-conditional ... meaning that it is safe for a patient with a Biotronik Eluna pacemaker with the ProMRI technology to undergo a full-body MRI scan under the condition that the settings on this pacemaker are properly set to their MRI conditional settings.

... sometimes I worry that announcements like these can be misinterpreted and could lead to something bad happening. I've seen an article regarding a Biotronik pacemaker that stated that the pacemaker was "MRI-safe" when it wasn't true. As of this date and as far as I know, there are no MRI-safe pacemakers. The one's where the FDA has approved MRI compatibility are all MRI-conditional.

Here are links to two articles announcing FDA's approval:

http://www.businesswire.com/news/home/20150320005438/en/FDA-Approves-BIOTRONIK-Eluna-Pacemaker-System-Full-Body#.VQ0Cr1zDZZU

http://www.dotmed.com/news/story/25371

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What this is about ...

A technical blog is dedicated to discussing aspect of the next generation of patient monitoring and management. I post new entries as I am able. I encourage you to become a follower. If you have an interest in this area, I think you will not be disappointed.

I am a technologist of long standing and I often can spot technical trends of an industry or of a particular company. I'm unconcerned with the financial or business impact. That is for others to consider. I'm interested in technology and its likely impacts on people's lives. Although my profile mentions that my most recent experience is with Medtronic. I had lengthy experience with St. Jude Medical. Any examples I provide do not necessarily originate from Medtronic or St. Jude Medical. I have contacts from a variety of medical device companies and constantly research the industry. My examples will originate from a variety of sources.

In the spirit of what I've written above, many may not know that a quiet revolution in medicine is occurring. The information highway, the Internet, is being extended into medicine. Wireless data communication with the Internet will be enlisted to enable people to connect with the Internet. The interchange of electronic patient records and digitized medical images are just a part of this revolution. In the near future, your physician can monitor your health remotely. Furthermore, if you have an implanted medical device (IMD) such as a pacemaker, ICD, neuro-stimulator, diabetes management device, etc., your physician can monitor your vital signs and change the settings on your implanted, therapeutic device remotely - virtually anywhere. Even very sick individuals could be enabled to live their lives at home rather than in an institution such as a hospital or nursing facility This can be performed safely and securely, and cost-effectively to provide people will fuller and longer lives.

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