Back in November 2013 we covered the news that Biotronik had gained the FDA’s acquiescence to enter phase B of its ProMRI® study. Now the agency has said the company can move onto phase C which will study the company’s ProMRI technology in implantable cardioverter-defibrillator (ICD) devices.
Biotronik tells us it’s the only company in the world with an ICD that is approved for investigational use in an MRI scanner. The Iforia platform is its latest generation of ICDs, claiming uncompromised longevity and daily monitoring through the pioneering Biotronik Home Monitoring® system.
Phase A of the The ProMRI® trial had evaluated the safety of Biotronik’s existing dual- and single-chamber Entovis pacemaker systems during MRI scans, but excluded chest and thorax scan areas. Phase B evaluated the same pacemaker system during MRI scans without exclusion zones and has already enrolled more than 100 of the planned 245 patients, and will continue concurrently with the newly approved ICD phase of the study.
So now we’re moving from pacemakers to ICDs: Phase C of the ProMRI® clinical study aims to determine whether ICD patients can safely undergo MRI scans with an exclusion zone. The study will recruit and evaluate 172 patients at 35 U.S. investigational centers. The study is designed to confirm the safety and efficacy of the Iforia devices, with Setrox and Linoxsmart leads during an MRI scan.
The FDA will review each phase of the study as part of Biotronik’s PMA application.
All the devices in the study are currently commercially available, but still await FDA approval for use in the MRI environment.
“This technology will finally allow full diagnostic capabilities for our patients who are more likely to need MRI scans,” said Theofanie Mela, M.D., Director of Pacer and ICD Clinic at Massachusetts General Hospital in Boston. “MRI is a safe and reliable diagnostic technology, and demand for imaging studies is growing. ICD patients are frequently recommended for MRI scans, but until now they have been unable to receive them. We are very excited to be participating in the ProMRI trial.”
“In the last three months, the clinical study sites have completed half of the Phase B enrollments, and I expect that momentum to continue through Phase B and as we begin Phase C,” said Kevin Mitchell, Vice President, Clinical Studies at Biotronik, Inc. “There is real enthusiasm to bring this meaningful advancement to patients; it’s very positive and palpable throughout the study sites.”
Source: Biotronik, Inc., Business Wire