March 25, 2014 — Biotronik has announced the U.S. Food and Drug Administration (FDA) has approved the expansion of Biotronik’s ongoing ProMRI clinical 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 a magnetic resonance imaging (MRI) 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 Nov. 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.
MRI scans often provide improved diagnostic capabilities for certain diseases or conditions that cannot be adequately examined by X-ray, computed 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 European Union 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.
For more information: www.biotronik.com