Biotronik obtains FDA clearance to expand ProMRI clinical trial

17 March 2014 (Last Updated March 17th, 2014 01:00)

German manufacturer of cardiac devices Biotronik has obtained US Food and Drug Administration (FDA) approval to expand its ongoing ProMRI trial.

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German manufacturer of cardiac devices Biotronik has obtained US Food and Drug Administration (FDA) approval to expand its ongoing ProMRI trial.

The latest phase (phase C) of the ProMRI clinical study is designed to determine whether implantable cardioverter-defibrillator (ICD) patients can safely undergo MRI (magnetic resonance imaging) scans with an exclusion zone.

The study will recruit and evaluate 172 patients at 35 US investigational centres.

Biotronik is reportedly the only company with an ICD that is approved for investigational use in an MRI scanner.

The ongoing ProMRI study is the first step in making this standalone technology available in the US.

Director of pacer and ICD clinic at Massachusetts General Hospital in Boston Dr Theofanie Mela said: "This technology will finally allow full diagnostic capabilities for our patients who are more likely to need MRI scans.

"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), which was completed on 18 November 2013, assessed the safety of Biotronik's Entovis pacemaker systems during MRI scans excluding chest area. Currently, the FDA is conducting its review of the pre-market application.

Earlier in the 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 without exclusion zones.

This 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.

"This 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."

Biotronik clinical studies vice-president Kevin Mitchell said: "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.

"There is real enthusiasm to bring this meaningful advancement to patients; it's very positive and palpable throughout the study sites."

The ICD ProMRI with exclusion zone study is designed to evaluate the safety and efficacy of Biotronik's Iforia devices, with Setrox and Linoxsmart leads during an MRI scan.

Currently, all the devices in the study are 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.

According to GlobalData estimates, ICD's market in the US, which was valued at $1.94bn in 2012, is expected to grow at a CAGR of 2.5% to reach $2.3bn by 2019.


Image: ProMRI now with full-body scan technology. Photo: courtesy of Biotronik SE & Co KG.