Biotronik, a medical device manufacturer based in Germany, announced that it received CE Mark clearance from the European Union for its Ilesto 7 series ICD/CRT-D implants. According to a press release by the company, these implants include specialized technology that makes them safe for use in MRI machines.
In its press release, the company provided further detail about its Ilesto 7 product line. The Ilesto 7 product line comprises one of the smallest cardioverter-defibrillators in the world and a specialized cardiac resynchronization therapy defibrillator.
In prepared remarks, a spokesman for Biotronik said, "The 1st implantations of the Ilesto 7 second-generation ProMRI devices are currently taking place across Europe." He continued, "With its new Ilesto 7 series and existing Lumax 740 ICD/CRT-D series that was launched in the European market in April 2012, Biotronik offers the world's only 2 ICD/CRT-D series approved for MR scanning."
Biotronik faces stiff competition in the MRI-friendly heart implant market. In early February, Medtronic landed approval with the FDA for its Advisa SureScan pacemaker. Like the new heart implant from Biotronik, the Advisa can be safely used in MRI machines. Medtronic has also received CE Mark approval in the E.U. for its MRI-safe neurostimulation implants.
Boston Scientific also joins the MRI-friendly implant party with its Ingenio and Advantio pacemakers featuring an MRI protection mode. Boston Scientific won CE Mark for these devices in July of 2012.