Germany-based Biotronik has announced that the first US patients have received its new Iforia implantable cardioverter-defibrillators (ICDs).
The ICDs were implanted soon after the company received US Food and Drug Administration (FDA) approval for a new phase of its ongoing ProMRI trial. The new phase is investigating the safety of ICDs in the MRI environment.
The company has performed its initial ICD surgeries for the study at hospitals in Connecticut, Pennsylvania, North Carolina, Michigan, Virginia, New York and Oregon, generally involving its Iforia devices.
Iforia is Biotronik’s latest generation of ICDs, which offers longevity and daily monitoring.
The expanded phase of the ProMRI clinical study will recruit and evaluate 172 patients at 35 investigational centres in the US.
The ICD ProMRI with exclusion zone study is designed to confirm the safety and efficacy of Biotronik’s Iforia devices, with Setrox and Linoxsmart leads during an MRI scan.
All devices in the study are currently commercially available, but still wait FDA clearance for use in the MRI environment.
The Biotronik-sponsored trial (NCT01761162) has been in US subject recruitment since March 2013.
Biotronik is reportedly the only company with an ICD that is approved for investigational use in an MRI scanner.
Annually, around 200,000 people in the US are implanted with ICDs and recent studies estimate 50% to 75% of these patients will develop a clinical need for an MRI scan over the course of their lifetime.
Biotronik clinical studies vice-president Kevin Mitchel said initial demand for participation in Phase C of the study has been robust.
"We are working closely with each of the sites to conduct the trial efficiently and effectively," Mitchel said. "Cardiac device patients and physicians express a clear need to access MRI scans. We expect this trial to take us one step closer to making that a reality."
According to GlobalData estimates, the US ICDs market was valued at $1.94bn in 2012, and 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.