Medtronic Gains FDA Approval for World’s Smallest Defibrillation Lead, Omniasecure

Medtronic has received FDA approval for its Omniasecure defibrillation lead, which it claims is the world’s smallest. Designed for use in the right ventricle, the lead connects to implantable defibrillators to detect and correct life-threatening arrhythmias. Built on the SelectSecure Model 3830 pacing lead, approved in 2018, Omniasecure features a lumen-less design and measures just 1.6 mm in diameter (4.7 French). This simplified structure allows placement using existing pacing catheters, potentially reducing vascular complications and valve interactions.

In a trial involving 657 patients, 19 major lead-related complications were reported within six months—11 were dislodgements, mostly within the first month. Other issues included P-wave oversensing and cardiac perforation, but no tricuspid valve complications occurred.

By differentiating it from older leads like the larger Sprint Quattro and the withdrawn Sprint Fidelis, Medtronic aims to improve safety and ease of use. The company reported modest growth in defibrillation sales earlier this year.

05-05-2025