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FDA approval (expanded indication) · Medtronic · Cardiology

OmniaSecure defibrillation lead

FDA approves the OmniaSecure defibrillation lead for left bundle branch area placement.

CompareMedtronic press release
Approved · PMA supplement

OmniaSecure defibrillation lead

Medtronic · Cardiology · First defibrillation lead for LBB area

Type
Implant
FDA route
PMA supplement
Bottom line for your practice
50s read

Patients who need both a defibrillator and pacing can now receive conduction system pacing through the defibrillation lead itself, placed in the left bundle branch area.

What it is
A lumenless defibrillation lead, delivered by catheter, that connects to an ICD or CRT-D to treat ventricular tachyarrhythmias, ventricular fibrillation and bradyarrhythmias. It can now be placed in the left bundle branch area as well as the right ventricle.
Indicated for
Patients who require chronic pacing and defibrillation therapy with a transvenous ICD or CRT-D; the lead is approved for adults and adolescent pediatric patients ages 12 and up.
What changes
The release says conduction system pacing uses the heart's natural electrical system and avoids cardiomyopathy or other complications sometimes associated with traditional pacing methods. It does not describe a comparison group in the trial.
Evidence
Design not reportedLEADR LBBAP (Lead Evaluation for Defibrillation and Reliability in Left Bundle Branch Area Pacing)The lead delivered high defibrillation success at implant (100%) and a low OmniaSecure-related major complication rate at three months (2.1%) when placed in the LBB area.The source does not describe a clinical study or its design. Common for cleared devices, which can rest on equivalence to a predicate.
Watch for
Reported results cover implant and three months; longer-term LBB area and LOT-CRT results were to be presented at HRS 2026. The release does not list contraindications or the number of patients studied.
FDA decision
  1. 510(k)Cleared
  2. De NovoGranted
  3. PMAApproved
PMA supplement. A change to a Class III device that already has premarket approval, here a new indication. The FDA reviewed the evidence for the change, not the whole device again; depending on the change, that may or may not include new clinical data.

Clinical summary

OmniaSecure is a lumenless, 4.7 French defibrillation lead that connects to an ICD or CRT-D; its expanded indication allows placement in the left bundle branch area for conduction system pacing. In the LEADR LBBAP trial, the company reports defibrillation success at implant of 100% and an OmniaSecure-related major complication rate at three months of 2.1%. The release does not give the number of patients, and longer-term results had not yet been presented.

From the source 7

Medtronic press release

The Medtronic press release's own words, quoted exactly. Each line is what a claim on this page was checked against.

  1. GALWAY, Ireland, March 23, 2026 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, received U.S. Food and Drug Administration (FDA) approval for an expanded indication for the OmniaSecure™ defibrillation lead.

    Backs · FDA approval of an expanded indication; date 2026-03-23 is the announcement date (the release does not give the FDA decision date)

  2. In addition to being the first defibrillation lead approved for placement in the LBB area, the OmniaSecure lead is the smallest diameter defibrillation lead on the market (4.7 French, or 1.66 mm) and the only one approved for adults and adolescent pediatric patients ages 12 and up.

    Backs · First defibrillation lead approved for LBB area; 4.7 French; ages 12 and up

  3. The OmniaSecure defibrillation lead connects to an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) to treat potentially life-threatening ventricular tachyarrhythmias, ventricular fibrillation (VT/VF), and bradyarrhythmias.

    Backs · Connects to ICD or CRT-D; conditions treated

View all 7 lines

  1. Late-breaking data from the study presented at Heart Rhythm 2025, and later published in Heart Rhythm, showed that the lead delivered high defibrillation success at implant (100%) and a low OmniaSecure-related major complication rate at three months (2.1%) when placed in the LBB area for physiologic pacing.2 Longer-term LBB area and LOT-CRT results from the study will be presented at HRS 2026.

    Backs · 100% defibrillation success at implant; 2.1% major complication rate at three months; longer-term results pending

  2. FDA approval for the OmniaSecure defibrillation lead was supported by data from the global LEADR LBBAP trial (Lead Evaluation for Defibrillation and Reliability in Left Bundle Branch Area Pacing), which demonstrated the lead's safety and effectiveness.

    Backs · Trial name

  3. Conduction system pacing works by tapping into the heart's natural electrical system, providing patients needed therapy while avoiding cardiomyopathy or other complications sometimes associated with traditional pacing methods.1

    Backs · Comparison with traditional pacing

  4. For patients who require chronic pacing and defibrillation therapy, the OmniaSecure lead can offer treatment for dangerously fast arrhythmias while delivering conduction system pacing through the LBB area, when connected to a transvenous ICD or CRT-D, such as the Medtronic Cobalt™ and Crome™ family of devices.

    Backs · Population: patients needing chronic pacing and defibrillation

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