Medtronic Wins FDA Approval for MRI-Accessible Pacemaker
Feb 14th 2013 9:32PM
Updated Feb 15th 2013 7:30AM
Medical device maker Medtronic announced in a press release yesterday that it has won FDA regulatory approval for its Advisa DR MRI SureScan pacemaker. The Advisa is Medtronic's second MR-conditional pacemaker, and just the second of its type to win U.S. regulatory approval.
Patients with pacemakers in the U.S. had previously been dissuaded from using MRIs before Medtronic's first SureScan MRI-compatible pacemaker won approval a few years ago. Accoridng to Medtronic's release, up to 75% of worldwide patients with implanted cardiac devices could need an MRI during their device's lifetime, making the company's product fill a valuable niche.
Dr. J. Rod Gimbel of Cardiology Associates of East Tennessee in Knoxville, Tenn commented on the interaction of pacemakers and MRIs in the release, saying:
MRI is just so very important and traditional pacemakers not FDA approved for MRI scanning often prevent the patient from having an MRI when they need it. With more than 85 percent of pacemaker patients being at least 65 years old and having multiple comorbidities for which MRI may be needed, it's key that physicians and patients have a pacing system that allows MRI imaging as a diagnostic procedure.
Medtronic expects to immediately launch the Advisa for marketing, with approval in hand.
The article Medtronic Wins FDA Approval for MRI-Accessible Pacemaker originally appeared on Fool.com.Fool contributor Dan Carroll has no position in any stocks mentioned. The Motley Fool owns shares of Medtronic. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.
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