http://pacemakerpeople.com/20/first-implant-of-mri-safe-pacemaker/ For People with Pacemakers & Their Friends Tue, 22 Jun 2010 17:34:41 +0000 http://wordpress.org/?v=2.9.2 hourly 1 http://pacemakerpeople.com/20/first-implant-of-mri-safe-pacemaker/comment-page-1/#comment-7 Jo Ann LeQuang Fri, 15 Jan 2010 20:44:37 +0000 http://pacemakerpeople.com/?p=20#comment-7 Hi, The pacer is not yet commercially available and it's hard to predict when the FDA will clear it. The lady in the story who got it was able to obtain it through a "compassionate use" waiver. To get that, you need to talk to your pacemaker doctor who has to apply for it. The FDA grants it. Your doc will also have to work with Medtronic to get it. Companies are usually not allowed to talk about product that is not approved. You're not getting the run-around, they just aren't supposed to discuss it. So work with your doctor. If you doctor is not helpful in this arena, find a pacing doc who is. If you need a list of some great pacemaker doctors, visit HRSonline.org, which is the official website of the Heart Rhythm Society. They have a section on there to help find a specialist. Good luck and let me know how you do--but you need a doctor to help champion this. Hi,
The pacer is not yet commercially available and it’s hard to predict when the FDA will clear it. The lady in the story who got it was able to obtain it through a “compassionate use” waiver. To get that, you need to talk to your pacemaker doctor who has to apply for it. The FDA grants it. Your doc will also have to work with Medtronic to get it.
Companies are usually not allowed to talk about product that is not approved. You’re not getting the run-around, they just aren’t supposed to discuss it.
So work with your doctor. If you doctor is not helpful in this arena, find a pacing doc who is. If you need a list of some great pacemaker doctors, visit HRSonline.org, which is the official website of the Heart Rhythm Society. They have a section on there to help find a specialist.
Good luck and let me know how you do–but you need a doctor to help champion this.

]]> http://pacemakerpeople.com/20/first-implant-of-mri-safe-pacemaker/comment-page-1/#comment-6 Debra Wenig Fri, 15 Jan 2010 17:07:09 +0000 http://pacemakerpeople.com/?p=20#comment-6 Jo Ann: I read your article.  I am desperate for specific info on when this MRI Safe pacemaker will be available, and/or how it can be obtained.  I have not been successful in obtaining info from manufacturer or from FDA.  If you could e mail me, I would be most grateful. Jo Ann: I read your article.  I am desperate for specific info on when this MRI Safe pacemaker will be available, and/or how it can be obtained.  I have not been successful in obtaining info from manufacturer or from FDA.  If you could e mail me, I would be most grateful.

]]>