MINNEAPOLIS–(BUSINESS
WIRE)–Medtronic, Inc. today announced the U.S. Food and Drug
Administration (FDA) approval and launch of the 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 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 Medtronics
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. Lukes 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 U.S.,
the DF4 High-Voltage Connector System is approved for use and available in most
geographies including 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
Cardiac Rhythm Disease Management business and senior vice president at
Medtronic. “Its a lead tested by time, coupled with the latest technological
advancements.”
About ICDs and CRT-Ds
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. Sudden cardiac death kills
more people each year than lung cancer, breast cancer and HIV/AIDS combined.
Medtronic estimates that more than 70,000 lives have been saved worldwide by implantable
defibrillators during the last five years.
About Medtronic
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical
technology – alleviating pain, restoring health, and extending life for
millions of people around the world.
Posted by Sean Fenske, Editor-in-Chief, MDT
