Irish medtech giant Medtronic has secured another US approval for its OmniaSecure defibrillation lead, expanding its use to placement in the left bundle branch (LBB) area of the heart.
Medtronic first commercially launched the lead in January 2026, designing it for use in conduction system pacing (CSP). It acts by monitoring and correcting a patient’s heart rhythm via an implantable defibrillator, which delivers high-energy shocks during arrhythmia or fibrillation events.
The US Food and Drug Administration (FDA) has approved OmniaSecure for use in the LBB area based on data from the LEADR study (NCT04863664), which found that the device delivered 100% defibrillation success at three months when placed in this region of the heart. OmniaSecure was also proven generally safe for use, with 2.1% of patients fitted with the lead experiencing major complications associated with the device.
The FDA previously gave OmniaSecure the regulatory green light for use in the right ventricle back in April 2025.
According to Medtronic, OmniaSecure has the smallest diameter of any defibrillation lead on the market, while being the only lead that is suitable for use in patients aged 12 and over. The device can be used in tandem with either a transvenous implantable cardioverter-defibrillator (ICD) or a cardiac resynchronisation therapy defibrillator (CRT-D).
OmniaSecure’s expanded approval builds on Medtronic’s legacy within the cardiac rhythm management devices (CRMD) market, which currently spans external and implantable defibrillators like the Cobalt and Crome device families, as well as pacemakers and ICD leads.
Looking at the CRMD market
With the Sudden Cardiac Arrest Foundation currently predicting that 350,000 Americans experience out-of-hospital cardiac arrest per year, there is a clear need for devices that can prevent these events.
This has led the medtech industry to develop a range of CRMDs to tackle this challenge, with implantable defibrillators being a gold standard choice for patients at risk of sudden cardiac arrest.
According to GlobalData’s Medical Devices Intelligence Center, Medtronic is the leading company in the CRMD sector based on the company’s 2025 revenue, making just under double in this sector compared to its nearest competitor, Abbott Laboratories.
GlobalData currently estimates that the CRMD segment will be worth just under $16bn in 2035 – ballooning at a compound annual growth rate of 4.1% from $10.7bn in 2025.
