Piedmont Heart Institute first in region to offer new treatment option for life-threatening heart arrhythmias

Atlanta, Ga. (January 22, 2026) – Piedmont Atlanta Hospital is the first in the southeastern United States to offer the OmniaSecure™ defibrillation lead, a novel advancement in transvenous defibrillation lead technology used within an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-Ds), such as the Medtronic Cobalt™ and Crome™ family of ICDs/CRT-Ds. Existing defibrillation leads are larger in diameter than the OmniaSecure lead, which at 4.7 French is the smallest defibrillator lead on the market. A larger-diameter lead may increase the potential for downstream complications, such as venous occlusion or tricuspid valve regurgitation.

A lead senses the heartbeat and transmits signals to the implanted device, which then delivers therapy to correct or interrupt abnormally fast rhythms that can result in sudden cardiac arrest (SCA). The OmniaSecure defibrillation lead was developed based on the Medtronic SelectSecure™ Model 3830 pacing lead, which has provided safe and reliable treatment to patients for more than 20 years. Ashish Bhimani, M.D., and Sandeep Goyal, M.D., performed the first implantation of the device at Piedmont Atlanta on January 7.

“Piedmont Heart Institute is a destination for cardiovascular care for patients from all 50 states, in part, because of our commitment to the early adoption of cutting-edge devices like the OmniaSecure defibrillation lead,” said Dr. Bhimani. “The smaller diameter of this catheter-delivered defibrillation lead is an important innovation because it allows for precise delivery and placement in the right ventricle.”

In 2025, the U.S. Food and Drug Administration (FDA) approved the Medtronic OmniaSecure™ defibrillation lead, which demonstrated safety and efficacy in patients who are at risk of SCA. The OmniaSecure defibrillation lead improves reliability while maintaining a strong safety profile and is indicated for adults and adolescent pediatric patients ages 12 and up, including those with smaller anatomies. It is the first defibrillation lead approved for both adults and adolescent pediatric patients ages 12 and up.

FDA approval was based on the LEADR Pivotal trial, a global clinical study that assessed the safety and effectiveness of the OmniaSecure defibrillation lead when placed at traditional locations in the right ventricle to achieve defibrillation, sensing, pacing and cardioversion in patients at risk of sudden cardiac death. The global clinical trial found that the OmniaSecure lead showed high defibrillation efficacy, low complications, and reliable performance, exceeding its pre-specified performance threshold.