A few weeks after the FDA allowed Biotronik to expand its ProMRI trial to implantable cardioverter-defibrillators, the company hasn't wasted any time moving ahead.
The German cardiac device company said it performed initial ICD surgeries for the study at hospitals in Connecticut, Pennsylvania, North Carolina, Michigan, Virginia, New York and Oregon, generally involving its Iforia devices.
Back in January 2013, the FDA approved Biotronik's plans to study its ProMRI technology in 245 pacemaker patients, exploring whether the technology would allow those patients to safely undergo an MRI. The expanded trial will recruit 172 ICD patients at 35 U.S. locations. Biotronik also gets the distinction of being the first in the U.S. to test whether an ICD can safely undergo a magnetic resonance imaging scan.
The ICD portion of the scan will test the use of Biotronik's Iforia devices with Setrox and Linoxsmart leads during MRI scans, with an exclusion zone in place. The company notes that all of these products are already commercially available but don't yet have FDA approval for use during MRIs.
Kevin Mitchell, vice president of clinical studies at Biotronik, said in a statement that the company is "working closely with each of the sites to conduct the trial efficiently and effectively. Cardiac device patients and physicians express a clear need to access MRI scans [and] we expect this trial to take us one step closer to making that a reality."
Biotronik is further ahead with this in Europe, where it already has a generation of MRI-safe ICDs approved for use.
In the U.S., Medtronic ($MDT) was the first to win approval of MRI-safe pacemakers, and Boston Scientific ($BSX) and St. Jude ($STJ) are working hard on gaining approvals for their own related products.
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