News | January 29, 2014

Biotronik Enrolls First Patients for ProMRI Clinical Trial Expansion

Study evaluates safety, effectiveness of pacemaker with ProMRI

Biotronik ProMRI Clinical Study Pacemaker EP Lab Magnetic Resonance Imaging

January 29, 2014 — Biotronik enrolled the first patients in an expansion of their ongoing ProMRI trial to test its pacemaker system.

Phase A of the study evaluated the safety of current Biotronik pacemaker systems during magnetic resonance imaging (MRI) scans with exclusion zones of the chest area, and was completed on November 18, 2013. The U.S. Food and Drug Administration (FDA) granted approval for Phase B, which will evaluate the safety of these pacemaker systems during MRI scans including cardiac or thoracic spine scans. 

The ProMRI clinical study aims to determine whether device patients can safely undergo full-body MRI scans, which can have negative effects on pacemakers and patients, and are therefore contraindicated for pacemaker patients. The study will recruit and evaluate 245 patients at 35 U.S. investigational centers. The ProMRI full-body scan expansion is designed to confirm the safety and efficacy of Biotronik’s existing dual- and single-chamber Entovis pacemaker systems and Setrox 53 and 60 cm leads during a MRI scan. Both devices are commercially available, but still await FDA approval for use in the MRI environment.

Entovis devices include Biotronik Home Monitoring technology, which provides daily monitoring of the patient’s device and ability to provide physiological therapy via Biotronik Closed Loop Stimulation (CLS). The Setrox active-fixation pacing leads have a flexible distal end, fractal coating, and steroid elution to for handling and stable fixation, as well as electrical performance.

The Biotronik-sponsored trial has been in U.S. subject recruitment since March 2013.

For more information: www.biotronik.com

Related Content

Breast Cancer Follow-up Imaging Varies Widely
News | Breast Imaging | July 13, 2018
July 13, 2018 — Follow-up imaging for women...
iSchemaView Brings RAPID Imaging Platform to Australia and New Zealand
News | Stroke | July 13, 2018
iSchemaView has signed Diagnostic Imaging Australia (DIA) to be the exclusive distributor for the RAPID cerebrovascular...
Lack of Insurance Coverage Delaying Proton Therapy Clinical Trials
News | Proton Therapy | July 12, 2018
Randomized clinical trials are the gold standard of cancer research and can shed light on whether innovative, new...
Breast Cancer Studies Ignore Race, Socioeconomic Factors
News | Women's Health | July 11, 2018
A new commentary appearing in the July issue of Cancer Causes & Control points to evidence that social factors help...
High-Strength MRI May Release Mercury from Amalgam Dental Fillings
News | Magnetic Resonance Imaging (MRI) | July 05, 2018
Exposure to ultra-high-strength magnetic resonance imaging (MRI) may release toxic mercury from amalgam fillings in...
Ensuring that the FMDS for MRI safety is mounted outside Zone IV provides maximum early warning.

Ensuring that the FMDS for MRI safety is mounted outside Zone IV provides maximum early warning. (Images courtesy of Metrasens)

Feature | Magnetic Resonance Imaging (MRI) | July 03, 2018 | By Tobias Gilk
Nearly every job in the country is subject to certain health and safety regulations. Construction workers must wear...
Researcher Investigates Eliminating Radiation for HER2-Positive Breast Cancer
News | Radiation Therapy | July 02, 2018
Researchers at The University of Kansas Cancer Center have launched a clinical trial that eliminates radiation from the...
Norwegian Study Confirms Higher Cancer Rate in Women with Dense Breast Tissue
News | Breast Density | July 02, 2018
A large Norwegian study using automated breast density measurements found that women with mammographically dense breast...
Technology | Magnetic Resonance Imaging (MRI) | June 27, 2018
June 27, 2018 — Zetta Medical Technologies announced the release of Zoom, its latest...
Overlay Init