Medtronic’s New Lead and Connector System OKd by FDA

The U.S. Food and Drug Administration (FDA) has approved Medtronic Inc.’s DF4 High-Voltage Connector System, a right ventricular lead and connector used with implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) to detect and accurately treat potentially life-threatening heart rhythms. The company has made an immediate launch of the system, which helps simplify implantation procedures via a redesigned port and provides additional reliability by giving physicians visual confirmation of the lead connection to the device.

The DF4 connector uses the same lead body as Medtronic’s Sprint Quattro lead, which has more than a decade of proven performance and a high safety and efficacy profile. The DF4 design includes fewer connections between the device and the defibrillation leads. Prior to the development of the DF4, traditional high-voltage connector systems required up to three connections. The DF4 connector has a single set-screw to connect the lead to the device and is available on several Medtronic ICDs and CRT-Ds, including the Protecta, Consulta and Secura portfolio of implantable defibrillators.

“With the availability of the DF4 system, implanting physicians now have access to the newest industry standard designed specifically around implant simplicity and system reliability,” said Brian Ramza, M.D., Evangeline and Frank Thompson chair in electrophysiology at the St. Luke’s Mid America Heart Institute in Kansas City, Mo. “This innovation addresses our need for easy-to-use, reliable technology that helps shorten the overall procedure time without compromising safety.”

In addition to the United States, the DF4 High-Voltage Connector System is approved for use and available in Europe, Japan, Canada and Australia.

“Medtronic is bringing U.S. physicians the reliability of the Quattro lead, which has 10 years of proven performance, along with the newest innovation in connection systems,” said Pat Mackin, president of the Minneapolis, Minn.-based firm’s Cardiac Rhythm Disease Management business and senior vice president at Medtronic. “It’s a lead tested by time, coupled with the latest technological advancements.”

ICDs and CRT-Ds are designed to provide painless pacing or life-saving shock therapy to stop fast or irregular heartbeats, also known as ventricular arrhythmias, which can lead to sudden cardiac death.