Medtronic Secures FDA Approval for World’s Smallest Defibrillation Lead

Medtronic has announced FDA approval of its Omniasecure defibrillation lead, a device that connects to implantable cardioverter defibrillators (ICDs) to treat life-threatening heart rhythm disturbances. Touted as the smallest defibrillation lead globally at just 1.6 mm in diameter, Omniasecure is based on the company’s Selectsecure Model 3830 pacing lead and is currently approved for placement in the right ventricle. Medtronic aims to offer a simpler, more compact lead that may help reduce risks such as vascular complications and valve interference.

The design eliminates the central lumen found in older models like Sprint Quattro and is narrower than the withdrawn Sprint Fidelis, which was removed from the market due to fracture concerns. Clinical trial data from 657 patients showed a low rate of serious complications, with lead dislodgement as the most common issue. Medtronic is exploring broader use cases, including placement in the left bundle branch, though FDA approval for that indication is still pending.