Medtronic has secured the US Food and Drug Administration (FDA) approval for its OmniaSecure defibrillation lead, designed for placement in the right ventricle.
OmniaSecure is designed based on the company’s SelectSecure Model 3830 pacing lead and is said to be the world’s smallest defibrillation lead, measuring 4.7 French or 1.6mm.
It connects to an implantable defibrillator, addressing life-threatening conditions like ventricular tachyarrhythmias and bradyarrhythmias.
The OmniaSecure lead is delivered via catheter and is intended for adults and adolescents aged 12 and above, including those with smaller anatomies.
Medtronic Cardiac Rhythm Management business chief medical officer Alan Cheng said: “FDA approval for the OmniaSecure defibrillation lead furthers our ability to offer physicians and patients a transvenous solution designed to be smaller to help minimise complications−including vascular complications and valve interaction−with strong, reliable lead durability.
“We engineered the OmniaSecure lead based on the trusted SelectSecure Model 3830 pacing lead, which has been the lead of choice for many physicians for more than 20 years.
“This milestone underscores our commitment to driving clinical innovations that help patients today while paving the way for future innovations that will usher in the next era of electrophysiology.”
In a recent announcement, Medtronic revealed findings from the global Lead Evaluation for Defibrillation and Reliability (LEADR) study.
The study confirmed that the OmniaSecure lead met its primary safety and effectiveness endpoints, surpassing prespecified performance goals when positioned in the right ventricle.
Defibrillation testing in 162 patients at implantation was successful in 100% of cases, exceeding the efficacy goal of 88%.
Among the 193 patients initially implanted in the LEADR study, the OmniaSecure lead was successfully placed according to protocol in 95.8% of procedures.
The study showed no major procedure-related complications such as helix or lead fracture, system revision, or death reported by physician investigators.
Medtronic is also exploring the potential of placing the OmniaSecure defibrillation lead in the left bundle branch area to further enhance its application in cardiac treatment.
In a separate development, Medtronic announced that the Expand URO Investigational Device Exemption (IDE) study achieved its primary safety and effectiveness endpoints.
The prospective, multi-centre, single-arm IDE study involved 137 patients undergoing urologic procedures using the company’s Hugo robotic-assisted surgery system.
The study national principal investigator Michael Abern said: “The study demonstrated that the Hugo RAS system met the safety and effectiveness endpoints, and the outcomes are consistent with published literature for robotic-assisted urologic surgery.
“Having performed the first case in the Expand URO clinical study, it’s incredibly rewarding to see the results of this rigorous and important study in the field of robotic surgery.”
