Medtronic Secures FDA Approval For OmniaSecure Defibrillation Lead In Right Ventricle Placement

(RTTNews) - Medtronic plc (MDT) said that it received U.S. Food and Drug Administration approval for the OmniaSecure defibrillation lead for placement within the right ventricle. The lead, built on the highly reliable SelectSecure Model 3830 pacing lead and delivered via catheter, builds on the Medtronic portfolio of lead solutions designed for precise delivery and placement.

The lead connects to an implantable defibrillator, and treats potentially life threatening ventricular tachyarrhythmias, ventricular fibrillation (VT/VF) and bradyarrhythmias. The OmniaSecure lead represents a meaningful innovation in electrophysiology, and is indicated for stimulation in the right ventricle for adults and adolescent pediatric patients ages 12 and up, including those with smaller anatomies.

Separately, the company is also studying placing the novel, small-diameter OmniaSecure defibrillation lead in the left bundle branch (LBB) area, which has the potential to enable physiologic pacing to more closely mimic the heart's natural conduction system. The results from the study demonstrate high defibrillation success of 100% at implant when the lead is implanted in the LBB area. Globally, the OmniaSecure defibrillation lead is investigational for use in LBB area and requires FDA approval in the future.

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