German medical device maker Biotronik won European regulatory approval for its Ilesto 7 line of MRI-friendly heart implants.
The Ilesto 7 line includes cardiac resynchronization therapy defibrillator and one of the world’s smallest implantable cardioverter-defibrillators, according to Biotronik.
"The 1st implantations of the Ilesto 7 second-generation ProMRI devices are currently taking place across Europe," the company said in a press release. "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."
MRI-friendly technology has caught the eye of some of the largest cardiac implant makers in the industry.
Earlier this month Medtronic (NYSE:MDT) won FDA approval to sell its Advisa pacemaker in the U.S.. The device features SureScan technology that, like the Ilesto 7, allows patients to receive MRI scans that normally pose a threat to traditional pacemaker function and patient safety.
The Minnesota medical device maker has also been touring its MRI-safe implants in the European Union and in Japan. Euro regulators recently approved Medtronic’s neurostimulation implants for compatibility with full-body MRI scanning.
In July 2012 Boston Scientific (NYSE:BSX) won CE Mark approval in the European Union for its line of Advantio and Ingenio pacemakers with “MRI Protection Mode.”