Medical device maker Medtronic (NYSE: MDT ) 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.