Medtronic Receives FDA Approval for OmniaSecure™, the World’s Smallest Lumenless Defibrillation Lead

Apr 27, 2025 22:15 CST Updated 22:15

Medtronic

Medical Device Manufacturer

Medtronic announces globalMinimum Diameter, No ChamberDefibrillation LeadsOmniaSecureApproved by the FDA for market release, can be used for right ventricular implantation.OmniaSecureConnected to an implantable defibrillator for the treatment of potentially life-threatening ventricular tachyarrhythmias, ventricular fibrillation (VT/VF), and bradyarrhythmias. As the world's smallest defibrillation lead (4.7 French, approximately 1.6 millimeters), the OmniaSecure lead represents a significant innovation in the field of electrophysiology and is suitable forRight Ventricular Pacing for Patients Aged 12 Years and Above, Including Adults and Adolescents, including patients with smaller anatomical structures.

PI Evaluation

"Left bundle branch area pacing provides a more physiological pacing option for ICD/CRT-D patients. Preliminary results demonstrate the potential of the OmniaSecure lead in anatomical adaptability."

---Pugazhendhi Vijayaraman Geisinger Wyoming Valley Medical Center

Executive Evaluation

"OmniaSecure is based on the SelectSecure Model 3830 pacing lead design, which has been clinically validated for over 20 years. While maintaining reliable durability, its smaller size helps reduce vascular complications and valve interactions. This milestone reflects our commitment to advancing electrophysiology innovation."

---Alan Cheng Chief Medical Officer of Arrhythmia Management, Cardiovascular Business at Medtronic

OmniaSecureThe rapid FDA approval was attributed to its excellent clinical data. According to the LEADR global pivotal trial published by Medtronic,OmniaSecureDemonstrating an excellent defibrillation success rate, low complication rate, and stable treatment performance.

Defibrillation efficacy rate at implantation 97.5% (exceeding expectations)
The incidence rate of major lead-related complications over a two-year period was only 3.1% (exceeding the target value).
Stable and reliable performance, zero lead fractures, and excellent electrical parameter performance
Implantation success rate as high as 97.9%, with 99.5% of leads accurately implanted in the right ventricular target site.

Of courseOmniaSecureIn addition to having right ventricular pacing, it alsoCanLeft bundle branch. Medtronic is currently making every effort to promoteOmniaSecureClinical Research on Left Bundle Branch (LBB) Area Implantation Aims to Achieve More Physiological Pacing Aligned with the Heart's Natural Conduction System. According to current research data, when the lead is implanted in the left bundle branch area, the defibrillation success rate reaches 100% at the time of implantation. After the clinical introduction, Medtronic will submit a registration application to the FDA.

OmniaSecure

OmniaSecureBased on the highly reliable SelectSecure Model 3830 pacing lead design, it is currently globalThe smallest diameter, chamber-free defibrillation lead.

OmniaSecureConsists of the following components

OmniaSecure Advantages

Minimum Diameter Defibrillation Lead

The world's smallest defibrillation lead, with a diameter of only 4.7 Fr (1.6 mm), is 64% smaller than the Sprint Quattro defibrillation lead.

High Implantation Success Rate

Achieve right ventricular target positioning through the delivery system, with 99.5% of leads accurately implanted at the target site.

Highly Reliable Structural Design

Designed based on the clinically proven SelectSecure 3830 pacing lead platform

No lumen structure design, durability verified through rigorous mechanical stress testing

Bench Test: Predicted 10-Year Fracture-Free Rate Up to 98.2%

Multifunctional Treatment Assurance

Integrated bipolar single-coil design, supports DF4 interface connection

Synchronously achieve pacing, sensing, cardioversion, and defibrillation functions

MRI SureScan Technology is Compatible with MRI Scans

Offering a variety of catheter options to meet the needs of different anatomical structures

Medtronic

Medtronic is a global leader in medical technology, with the mission of "alleviating pain, restoring health, and extending life." Through innovative technologies, it transforms the lives of millions of people worldwide each year. Its products cover 70 disease areas, including cardiac devices, surgical robots, and insulin pumps. More than 95,000 employees are committed to advancing the future of human health through insight-driven healthcare solutions.