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| Biotronik's Idova 7 implantable cardioverter defribillator--Courtesy of Biotronik |
Germany's Biotronik is rolling out a new line of implantable cardioverter defibrillators meant to be safe for MRI use, an advance that has proliferated in Europe.
The Berlin-based cardiac device company will start selling its Idova 7 implantable cardioverter defibrillators, which it bills as the most powerful ICDs approved for MR scanning. Initial implants have taken place in Austria and Italy.
Biotronik said the product line represents the next generation of its ProMRI technology that enables production of pacemakers and defibrillators safe for full MRI use. In August, the company disclosed it had extended ProMRI to its Evia single- or dual-chamber CRT pacer, as well as products such as its Ilesto and Iforia ICDs/CRT-Ds.
Pacemaker and defibrillator sales have grown generally stagnant in the U.S. and Europe. Developing MRI-safe iterations has been a way to inject something new into the market and allow patients to broaden their care options. Europe has become far more advanced with the approval of MRI-safe implants such as defibrillators and pacers, and major companies such as Medtronic ($MDT), St. Jude Medical ($STJ) and Boston Scientific ($BSX) have all been in the game, winning approval for MRI-safe pacers in Europe, Japan and elsewhere.
In the U.S., the process is much slower. Medtronic has its Revo MRI-safe pacer cleared for U.S. use. St. Jude is testing its Accent MRI pacemaker with an eye on a U.S. submission, and Boston Scientific and others are hard at work with their own MRI-safe pacer/defibrillator product developments. MRI-safe implants may not be needed in the long run, however. A major study published last year in the American Journal of Cardiology challenged whether MRI-safe implants were even necessary, noting that physician precautions such as calibrating device rhythm to the MRI's magnetic field or turning devices off during an MRI scan ensured a safe process and device workability.
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