Medtronic receives FDA approval for smallest defibrillation lead of its kind

Medtronic has received U.S. Food and Drug Administration (FDA) approval for its OmniaSecure defibrillation lead for placement within a patient’s right ventricle. The lead is delivered through the use of a catheter and connects to an implantable defibrillator to help treat ventricular tachyarrhythmias, ventricular fibrillation or bradyarrhythmias in patients 12 years old and older.

According to Medtronic, the size of the OmniaSecure—4.7 French, or 1.6 mm—makes it the smallest defibrillation lead with no lumen in the world. The company emphasized the value this can provide by reducing the risk of complications. It is also viewed as a step forward in quality when treating younger patients or those with an especially small anatomy.

“FDA approval for the OmniaSecure defibrillation lead furthers our ability to offer physicians and patients a transvenous solution designed to be smaller to help minimize complications−including vascular complications and valve interaction−with strong, reliable lead durability,” Alan Cheng, MD, chief medical officer of Medtronic’s cardiac rhythm management business, said in a prepared statement. “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.”