St Paul, Minnesota -- St Jude Medical Inc., a global medical device company, has received US Food and Drug Administration (FDA) approval of its Unify Quadra cardiac resynchronisation therapy defibrillator (CRT-D) and Quartet left ventricular quadripolar pacing lead.
The Quartet pacing lead features Optim insulation, which St Jude said is designed to "combine the biostability and flexibility of high-performance silicone rubber with the strength, tear resistance and abrasion resistance of polyurethane, to provide increased durability."
The Unify Quadra CRT-D and Quartet lead system integrates multiple pacing configurations and features that enable physicians to optimise the system at implant and follow-up, as well as better manage common pacing complications without having to surgically reposition the lead, the medical device company said.
"The Unify Quadra system allows me to deliver effective CRT therapy by programming different lead configurations rather than surgically repositioning the lead itself," said Dr Charles Gornick, of the Minneapolis Heart Institute at Abbott Northwestern Hospital, in the news release.
"This new technology makes it possible to further tailor CRT therapy by being able to select different pacing vectors and adds to my potential options for treating patients who do not respond to CRT therapy," he added.
Cardiac resynchronisation therapy resynchronises the beating of the heart's lower chambers (ventricles), which often beat out of sync in heart failure patients.
Studies have shown that CRT can improve the quality of life for many patients with heart failure, a progressive condition in which the heart weakens and loses its ability to pump an adequate supply of blood. Some 23 million people worldwide are afflicted with congestive heart failure (CHF), and 2 million new cases of CHF are diagnosed each year worldwide.