Features | Partner Sites | Information | LinkXpress
Sign In
GLOBETECH PUBLISHING LLC
Ampronix
Schiller

Approval of Expansion of Cardioverter Defibrillator Trial to Include MRI Full-Body Scans

By Medimaging International staff writers
Posted on 03 Jun 2014
A new magnetic resonance imaging (MRI)-compatible, implantable cardioverter defibrillators (ICDs) provide physicians with the complete diagnostic capabilities of a dual-chamber ICD, including atrial sensing and sophisticated shock reduction algorithms with only one lead.

Biotronik (Berlin, Germany), a manufacturer of cardiovascular medical devices, reported that the US Food and Drug Administration (FDA) has approved a significant expansion of its ongoing ProMRI trial. The approval will allow patients enrolled in phase C of the trial to receive full-body scans, and for the first time, include patients with DX ICDs in the study.

Biotronik, in 2011, received CE marking of approval and became the first company worldwide with an ICD approved for use in a MRI scanner. The ProMRI study is the next step in making this technology widely available in the United States. Biotronik introduced DX technology in 2013 in the United States, and it has been rapidly accepted by US electrophysiologists. Patients prefer implants with less hardware while physicians benefit from dual-chamber diagnostic data.

“With the DX system, I gain important diagnostic and therapeutic information. For my primary prevention patients with no dual chamber pacing indication, the implant procedures are straightforward, and it makes sense to use as little hardware as possible,” said Harpreet S. Grewal, MD, FACC, FHRS, from Richmond Cardiology Associates (Richmond, VA, USA). “The potential to provide this therapy and have it approved for use in full-body MRI conditions adds clinical value.”

Phase C of the ProMRI trial is the final phase in a series of MRI compatibility trials conducted by Biotronik in rapid succession. Phase A and phase B of the trial evaluated the safety of Biotronik Entovis pacemaker systems during MRI scans. Phase A resulted in FDA approval on May 6, 2014, of Entovis systems for MRI scans with an exclusion zone. Phase B expanded the trial to evaluate the safety of Entovis pacemaker systems for full-body scans, including cardiac and thoracic spinal scans. Phase B is nearing completion and data will soon be submitted to FDA.

“We are anxiously awaiting the day when this important diagnostic capability, up to now only available to pacemaker patients, can also benefit ICD patients,” said Kevin Mitchell, vice president, clinical studies at Biotronik, Inc. “Biotronik is committed to extending its ProMRI technology to as many patients as possible. We were the first company to offer ICD patients in the United States MRI access, and remain the only company that provides single-chamber pacemaker patients access to this diagnostic tool.”

Every year, about 200,000 patients in the United States are implanted with ICDs, and studies estimate that 50%–75% of them will develop a clinical need for an MRI scan during their lifetime. MRI scans frequently provide improved diagnostic capabilities for specific 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 to enable all cardiac rhythm patients’ access to MRI scanning. ProMRI technology is already used widely in Europe, including recent CE approval for MR-Conditional full-body and 3.0 Tesla scans with the Ilesto/Iforia ICD system. The Biotronik -sponsored trial has been in US subject recruitment since March 2013.

Related Links:

Biotronik



Channels

Radiography

view channel

Pioneer in Orthopedic Imaging to Provide Novel Online 3-D Modeling Service for Hospitals

A company that pioneered 2-D/3-D orthopedic medical imaging has announced a new personalized 3-D image modeling service using stereo-radiographic patient images, for hospitals and healthcare professionals worldwide. The service will be able to generate 3-D models, and related clinical data, to support therapeutic decision... Read more

Ultrasound

view channel
Image: World’s first 29 MHz micro-ultrasound system (Photo courtesy of Exact Imaging).

Breakthrough High-Resolution Micro-Ultrasound Platform for the Prostate Revealed at AUA 2015

A novel micro-ultrasound imaging platform has been introduced at the annual meeting of the American Urological Association (AUA) 2015 (New Orleans, LA, USA). The probe operates at 29 MHz, and enables... Read more

Nuclear medicine

view channel
Image: PET scan images (Courtesy of King’s College London).

Preventing Unnecessary Radiotherapy for Patients with Early-Stage Hodgkin’s Lymphoma

A new study suggested that patients with early-stage (stage 1a or 2a) Hodgkin’s lymphoma disease, who underwent three cycles of chemotherapy with the drugs doxorubicin, bleomycin, vinblastine, and dacarbazine... Read more

General/Advanced Imaging

view channel

Global Healthcare Study of Coronary Artery Disease Reaches Significant Milestone

A major milestone has been reached in the Lipid-Rich Plaque (LRP) study, a prospective, multicenter clinical trial with the potential to reveal breakthrough correlations between Lipid-Rich Plaques and occurrence of heart attacks. The LPR study has now enrolled 1,000 patients, and aims to identify a correlation between... Read more

Imaging IT

view channel
Image: Clinical Collaboration Platform (Photo courtesy of Carestream Healthcare).

New, Advanced Medical Imaging and Healthcare IT Products Showcased in HIT Expo in Paris

A medical imaging systems and Information Technology (IT) solutions provider has demonstrated its advanced imaging IT platform and product updates at Health-IT (HIT) Expo 2015 on May 19–21, in Paris (France).... Read more

Industry News

view channel

Advanced Medical Imaging Startup Company Receives Venture Funding

Zebra Medical Vision (Kibbutz Shfayim, Israel) has received an USD 8 million investment from Khosla Ventures (Menlo Park, CA, USA) to double its team, set up headquarters in the US and increase its scope of work to integrate data from additional Health Maintenance Organizations (HMO). Zebra Medical has already partnered... Read more
 
Copyright © 2000-2015 Globetech Media. All rights reserved.