Feature | March 25, 2014

First ICD to be Evaluated in U.S. Clinical Trials for Use in MRIs

Biotronik to enroll ICD patients in ProMRI trial

biotronik, MRI safe ICD

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

Related Content

Hitachi Medical Systems America, HMSA, Evolution 5, MRI software platform, Echelon Oval, RSNA 2015

Echelon Oval image courtesy of Hitachi Medical Systems America Inc.

Technology | Magnetic Resonance Imaging (MRI)| November 24, 2015
In conjunction with the upcoming Radiological Society of North America (RSNA) 2015 exhibition, Hitachi Medical Systems...
News | Heart Valve Repair| November 23, 2015
NaviGate Cardiac Structures Inc. (NCSI) announced that a first-in-human implant of its catheter-guided, mitral-valved...
iRhythm Technologies, ZIO continuous cardiac monitoring service, myZIO app, irregular heartbeat symptoms, reporting

Image courtesy of iRhythm Technologies

Technology | ECG Monitoring Services| November 19, 2015
iRhythm Technologies Inc. announced the launch of new patient engagement tools to enhance the diagnosis of cardiac...
Fraunhofer MEVIS, MRI, CaFuR, real-time MRI, beating heart

The software developed by Fraunhofer MEVIS automatically identifies the breathing and heart contraction phases in the data independent of the ECG information. This allows for a fast and easy examination of heart patients. Image courtesy of Fraunhofer MEVIS.

News | Magnetic Resonance Imaging (MRI)| November 18, 2015
Today, magnetic resonance imaging (MRI) allows more gentle, precise and cost-effective heart disease diagnosis. However...
Kopp Development, FerrAlert FILM, Ferrogmagnetic Incident Log Manager, Joint Commission standards

The FerrAlert Ferromagnetic Incident Log Manager (FILM) device is designed to work exclusively with Kopp Development's FerrAlert Halo II Plus MRI entryway system, pictured above. Image courtesy of Kopp Development Inc.

Technology | Magnetic Resonance Imaging (MRI)| November 17, 2015
Kopp Development Inc. announced the release of the new accessory for their latest magnetic resonance imaging (MRI)...
wearable Holter monitors, iRhythm, ziopatch, zio patch

iRhythm Technologies Zio Patch was among the first of a new generation of simplified, wearable Holter monitors designed to increase ease of use and patient compliance to increase detection of arrhythmias that may lead to stroke.

Feature | Holter Monitoring Systems| November 16, 2015 | Judy Lenane, RN, MHA
One-third of ischemic strokes are classified as cryptogenic.
GE Healthcare, MRI, RSNA 2015, Signa Explorer, Signa Creator, Signa Pioneer

Signa Explorer image courtesy of GE Healthcare

News | Magnetic Resonance Imaging (MRI)| November 16, 2015
At this year’s Radiological Society of North America (RSNA) annual meeting, GE Healthcare is showcasing continued...
protein reprogramming, Stem Cells Translational Medicine, cardiac progenitor cells, CPCs, regenerative therapies
News | Stem Cell Therapies| November 13, 2015
A new study appearing in STEM CELLS Translational Medicine (SCTM) describes a highly efficient, protein-based method...
angina, abnormal heart blood flow, female-pattern heart disease, Cedars-Sinai Heart Institute study, AHA Scientific Sessions
News | Cardiac Diagnostics| November 13, 2015
Chest pain in female-pattern heart disease is linked with abnormal heart blood flow, a new Cedars-Sinai Heart Institute...
News | Antiplatelet and Anticoagulation Therapies| November 12, 2015
Preventing blood clots with drugs such as heparin has become a common practice for fighting some heart and lung...
Overlay Init