The US Food and Drug Administration (FDA) has granted approval for Medtronic’s OmniaSecure defibrillation lead intended for insertion in the right ventricle.
This new 4.7 French (1.6mm) lead, which the company claims is the smallest in the world, is built on the SelectSecure Model 3830 pacing lead and delivered through the catheter.
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It is designed to connect to an implantable defibrillator and addresses potentially fatal conditions such as bradyarrhythmias, ventricular tachyarrhythmias and ventricular fibrillation (VT/VF).
This lead is intended for use in adults and adolescent paediatric individuals who are aged 12 years and above, including those with smaller anatomies, indicated for stimulation in the right ventricle.
Medtronic is also conducting studies on the placement of the OmniaSecure defibrillation lead in the left bundle branch (LBB) region.
This approach could enable physiologic pacing that closely resembles the natural conduction system of the heart.
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By GlobalDataThe study’s outcomes have shown a 100% defibrillation success rate at implant when positioned in the LBB area.
However, the use of OmniaSecure in the LBB area remains investigational globally and is pending FDA approval.
As it is smaller in diameter than existing defibrillation leads, Medtronic’s lead may minimise the risk of complications such as venous occlusion or tricuspid valve regurgitation.
The global Lead Evaluation for Defibrillation and Reliability (LEADR) Pivotal Trial’s late-breaking data, presented by the researchers previously, indicated that the OmniaSecure met its primary effectiveness and safety endpoints.
Furthermore, the outcomes from the non-randomised LEADR LBBAP study demonstrated high defibrillation success of the lead when positioned in the LBB area for individuals requiring an implantable cardioverter-defibrillator (ICD) or cardiac resynchronisation therapy defibrillator (CRT-D).
Medtronic cardiovascular portfolio’s cardiac rhythm management business chief medical officer Alan Cheng said: “FDA approval for the OmniaSecure defibrillation lead furthers our ability to offer physicians and patients a transvenous solution designed to be smaller to help minimise complications−including vascular complications and valve interaction−with strong, reliable lead durability.”
Prior to this development, the company received the agency’s approval for its disposable Simplera Sync sensor to be used with the MiniMed 780G system.
