Medical Device Daily
Medtronic (Minneapolis) reported 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 is really a connector and the advantage of this connector is that it's all in line, meaning it's easier to put in [patients]. That's the number one advantage,“ David Steinhaus, VP and Medical Director for Medtronic told Medical Device Daily. “The second advantage is that the connector block itself is less blocky and the pocket is actually smaller so the device can be a little bit smaller.“
He added the other advantage is that since “[the device] is easier to put in, there is less chance of making a mistake with multiple connections.“
The DF4 connector uses the same lead body as Medtronic's Sprint Quattro lead, which has what the company calls a decade of proven performance and a high safety and efficacy profile. 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.
“We chose to put that connector on the Quattro lead, because we actually wanted to alter the Quattro lead as little as possible,“ Steinhaus said. “The reason being, is because the performance of the Quattro lead has been fantastic. It's clearly the best defibrillator lead on the market with 10 years of performance.“
He added that leads are the weak part of the system and that Medtronic as well as its competitors have had to deal with lead issues in the past.
Nearly two years ago Medtronic reported settling claims surrounding its Sprint Fidelis family of defibrillation leads which the company recalled back in 2007 (Medical Device Daily, Oct. 15, 2010). After identifying five patient deaths in which a Fidelis lead fracture may have been a contributing factor, the company recalled the leads in October 2007, saying that the leads may break inside the body. Roughly 268,000 leads had been implanted by the time of the recall (MDD, Oct. 16, 2007).
The med-tech giant's competitor St. Jude (Rochester, Minnesota) had a lead called Riata 7 Fr ICD, that underwent particular scrutiny and review when doctors and investors wondered if it would be recalled next because the recall made the Riata 7 Fr the smallest lead on the market (MDD, Oct. 31, 2007).
St. Jude was quick to point out design differences that separated the two leads. In the Riata leads, for instance, the coil conductor is central, with the cable conductors arranged symmetrically around the coil in order to provide mechanical protection. In contrast, an asymmetrical design is used in the Fidelis leads, with the coil at one side and the cable conductors on the other so they are not protected from outside mechanical forces.
Medtronic's latest application is aimed in a different direction and is pointed out for its ease of use. “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 Frank Thompson chair in electrophysiology at the St. Luke's Mid America Heart Institute (Kansas City, Missouri). “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.
“There are over 5,000 implanted already,“ Steinhaus said. “It's not a gamechanger - it's a convenient thing to have. Our strategy most recently has been to make these implants more simple and easy ... not only for physicians but for patients. This is one of those devices where you can't say it changes the entire game, but it does, on the other hand, offer a nice convenient easy-to-use feature which people like.“
Omar Ford, 404-262-5546;
Published: January 31, 2012