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Medtronic (New York Stock Exchange: MDT) said a clinical study for its Affera ablation and mapping system with Sphere-9 catheter for the treatment of persistent atrial fibrillation has met its endpoints for safety and efficacy.
The study compared the Sphere-9 catheter with that of Johnson & Johnson (JNJ) Thermocool Smarttouch SF radiofrequency ablation catheter with the Carto 3 system. The results of the study were presented at the Heart Rhythm Society annual meeting and published in Nature medicine, according to medtronic.
Medtronic recently submitted a marketing application to the FDA for the Affera Sphere-9 catheter. The Affera ablation and mapping system, which includes the Sphere-9 catheter, received European approval in March.
