Medtronic Inc. (NYSE:MDT) landed FDA clearance for its DF4 high-voltage right ventricular lead for use with implantable cardiac rhythm management devices.
The DF4, which builds on Medtronic’s Sprint Quattro lead, aims to help simplify the implantation process with a redesigned port and by providing visual confirmation of the lead’s connection to the device.
"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," cardiac rhythm disease president and senior VP Pat Mackin said in prepared remarks. "It’s a lead tested by time, coupled with the latest technological advancements."
The Quattro device has a single set-screw to connect to the lead to a device, where traditional high-voltage connector systems require up to three connections, according to a press release.
The new lead will work with several Medtronic implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators, including the company’s Protecta, Consulta and Secura lines.
The Fridley, Minn.-based med-tech titan has had a lot of regulatory news this month, including closing enrollment for the “extreme-risk” population of its CoreValve transcatheter aortic valve implantation study, initial patient enrollment in its Fire & Ice cardiac ablation study and CE Mark approval and commercial launch of the Endurant II stent graft in the European Union.
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