BIOTRONIK, a leading manufacturer of cardiovascular medical devices, announced today that the Food and Drug Administration (FDA) has approved the expansion of BIOTRONIK’s ongoing ProMRI trial. The new phase of the trial (Phase C) will study the company’s ProMRI technology in implantable cardioverter-defibrillator (ICD) devices. BIOTRONIK is the only company in the world with an ICD that is approved for investigational use in an MRI (magnetic resonance imaging) scanner. The ongoing ProMRI study is the first step in making this standalone technology available in the United States.
“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.” The first phase of the ProMRI trial (Phase A) evaluated the safety of the BIOTRONIK Entovis pacemaker systems during MRI scans, excluding scans in the chest area. This phase was completed on November 18, 2013, and the FDA is now conducting its review of the Pre-Market application. Earlier that same month, the FDA had approved Phase B of the study, which expanded the trial to evaluate the safety of these pacemaker systems during MRI scans including cardiac and thoracic spine scans. Phase B has already enrolled more than 100 of the planned 245 patients, and will continue concurrently with the newly approved ICD phase of the study.
“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.” Every year, more than 300,000 people are implanted with ICD systems, and studies estimate that 50-75 percent of these patients will develop a clinical need for an MRI scan during their lifetime.1,2 MRI scans often provide improved diagnostic capabilities for certain diseases or conditions that cannot be adequately examined by X-ray, computerized tomography (CT) or ultrasound. The strong forces applied during an MRI scan can have a negative effect on both device and patient, and are usually contraindicated for pacemaker and ICD patients. With its ProMRI technology, BIOTRONIK has developed a solution that is designed to enable all cardiac rhythm patients access to MRI scanning. The ProMRI technology is already widely used in EU countries.
The latest phase 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 ICD ProMRI with exclusion zone study is designed to confirm the safety and efficacy of BIOTRONIK’s Iforia devices, with Setrox and Linox smart leads during an MRI scan. All the devices in the study are currently commercially available, but still await FDA approval for use in the MRI environment.
The Iforia platform is BIOTRONIK’s latest generation of ICDs offering uncompromised longevity and daily monitoring through BIOTRONIK Home Monitoring ®. The BIOTRONIK-sponsored trial (NCT01761162) has been in U.S. subject recruitment since March 2013.
1 Morgan Stanley, ICD market, 1996–2009.
2 Roguin et al., Europace 2008, 10, 336-346.