Berlin-based Biotronik said Friday that the FDA has approved a major expansion of its ongoing ProMRI trial. The approval will allow Phase III trial patients to receive full-body MRI scans and, for the first time, will include patients with DX implantable cardioverter defibrillators.
The cardiovascular device manufacturer received CE mark approval in 2011 for an ICD for use in MRI scans, becoming the first company in the world to do so. The device is available in all countries that observe the CE Mark, the company said.
The ProMRI study is the next step in making DX technology widely available in the U.S. Biotronik’s ICD’s are commercially available in the U.S., but have not yet been approved for use in an MRI, spokesman Rex Richmond told Device Daily Bulletin.
Richmond said that MRI scans represent a major indication gap that the company is trying to fill. The DX ICD system was designed with MRI use in mind and did well in bench testing, he said.
The length of the trial will depend on how long it takes to enroll the planned 172 patients at 37 centers, Richmond said. Patients will be implanted with an ICD and, after five to six weeks, they return to receive an MRI scan, he explained.
Biotronik hopes to complete enrollment by the end of the year. But because no one has done a trail of this kind and the attrition rate is unknown, no timeline for completing the trial has been set, Richmond said. — Kellen Owings
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