FDA approves Biotronik's Iperia ICD (implantable cardioverter defibrillator) systems for use with MRI imaging- Biotronik

Biotronik has announced that it has received FDA approval for use of its Iperia ICD Systems being the latest family of implantable cardioverter defibrillator (ICD) systems with magnetic resonance imaging (MRI) scans. Biotronik ProMRI technology allows patients with approved device systems to have 1.5 Tesla MRI scans without an exclusion zone. ICD patients will have expanded access to MRI diagnostic scans, which can be critical for diagnosing conditions such as stroke, brain and cardiac tumours or orthopaedic injuries.

The Biotronik ProMRI ICD family approval includes the Iperia DR-T in both DF-1 and DF4 configurations; and the Iperia DX System, the only ICD hybrid that combines the benefits of both single- and dual-chamber devices. Also included is Inventra ProMRI DX, which is the only ICD available that offers ultra-high energy (42 Joules) on the first shock, for patients with complex heart conditions who may require a higher-powered first shock for effective therapy. The devices are MR conditional when used with appropriate Biotronik leads to complete the approved ProMRI system.

Comment: MRI scans are used to diagnose a multitude of conditions, especially those involving 'soft' tissue like heart, brain, muscles and liver. Seventy-five percent of patients with an implantable electronic device (pacemaker or ICD) will need an MRI in their lifetime. Until recently, people with ICDs were denied access to MRIs.