US firm submits PMA (premarket approval application) for defibrillation catheter:
This article was originally published in Clinica
Rhythm Technologies has filed a PMA application with the FDA for permission to market its disposable transvenous catheter that delivers low energy defibrillation to treat atrial and ventricular arrhythmias. The rhythm catheter "may be used in virtually every electrophysiology procedure and ablation procedure where arrhythmias are encountered" says the Jacksonville, Florida company, which already sells the product and its accessories in Europe. The firm's rhythm catheters are also approved in Japan, where launch efforts are underway.
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