FDA clears Biotronik’s full-body MRI-safe Iperia ICDs

Biotronik said last week it won FDA premarket approval for its Iperia family of magnetic resonance imaging-compatible implantable cardioverter defibrillators.

The approval includes Biotronik’s Iperia DR-T DF-1 and DF4 configurations, the Iperia DX and Iperia ProMRI DX, the company said.

“Our goal is to integrate ProMRI technology across our entire line of implantable systems, and in doing so, provide access to MRI diagnostic scans for all CRM patients. The ProMRI Study and subsequent FDA approvals have been part of a consistent and methodical process for making more MRI options available for U.S. cardiac device patients, starting with single- and dual-chamber pacemakers with an exclusion zone in May 2014, then full-body for the same pacemaker lines in March 2015, and now ICDs for full-body scans, including Biotronik’s unique DX device system. This is meaningful technology that will enhance the quality of healthcare for patients throughout their lives,” Prez Marlou Janssen said in a press release.

The newly approved line of ICDs include other features, such as Biotronik’s Closed Loop Stimulation rate response algorithm, a home monitoring system and the company’s DX atrial signal sensor.

Earlier this month, Biotronik said it enrolled the 1st patients in its BioSync CLS trial looking to examine whether its closed loop stimulation-equipped pacemakers can prevent syncope.

Recurrent syncope, or fainting, is often proceeded by a drop in blood pressure or heart rate, so patients diagnosed with the disorder are often indicated for pacemakers, Biotronik said.

The double-blinded, multicenter trial is slated to include 30 study centers in Europe and Canada and enroll 128 patients with a pacemaker indication for treating recurrent syncope. Patients will receive a Biotronik dual-chamber pacemaker with CLS either on or off, depending on their group.

The trial’s primary endpoint will compare time to 1st-recurrence of syncope between the groups, and the study will have a follow-up period of 2 years.

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