The U.S. Food and Drug Administration (FDA) recently approved Medtronic's (NYSE: MDT) DF4 High-Voltage Connector System.
Comprised of a right ventricular lead and connector, the Medtronic DF4 connector system is 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 says its FDA-approved DF4 connector system 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. The company says its DF4 design includes fewer connections between the device and the defibrillation leads. The company notes that prior to the development of the DF4, traditional high-voltage connector systems for similar applications required up to three connections. In contrast, the Medtronic 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.
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In addition to the U.S., the Medtronic DF4 connector system is approved for use and available in most geographies including Europe, Japan, Canada, and Australia.
"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," comments 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."
ICDs and CRT-Ds 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. Medtronic estimates that more than 70,000 lives have been saved worldwide by implantable defibrillators during the last five years.
"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 Cardiac Rhythm Disease Management business and senior vice president at Medtronic. "It's a lead tested by time, coupled with the latest technological advancements."
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