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FDA approves Medtronic DF4 High-Voltage connector system

The US Food and Drug Administration (FDA) has approved Medtronic's right ventricular lead and connector, DF4 High-Voltage Connector System.

The DF4 High-Voltage connector system is used in conjunction with implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) in order to detect and treat life-threatening heart rhythms.

The connector system features 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.

The DF4 system simplifies implantation procedures via a redesigned port and provides additional reliability by giving physicians visual confirmation of the lead connection to the device.

Medtronic senior vice president and Cardiac Rhythm Disease Management business president Pat Mackin said the company is bringing US physicians the reliability of the Quattro lead, which has 10 years of proven performance, along with the newest innovation in connection systems.

Medtronic said in addition to the availability in the US, the DF4 High-Voltage Connector System is also approved for use in most geographies including Europe, Japan, Canada, and Australia.