St Paul, Minnesota -- Global medical device company St Jude Medical has launched its Promote Quadra cardiac resynchronisation therapy defibrillator (CRT-D) in Europe. St Jude said the device "is the industry's first quadripolar pacing system, which offers physicians the ability to more effectively and efficiently manage the ever-changing pacing needs of patients with heart failure."
According to St Jude, the device integrates multiple pacing configurations and features so that physicians can optimise the system at implant and follow-up, as well as better manage common complications without having to surgically reposition the lead.
"The Promote Quadra CRT-D gives me a greater number of less-invasive methods for managing my heart failure patients using CRT and reduces my patients' risk of needing multiple surgical procedures. The Quartet lead also allows me more options for placing the pacing lead, without any compromises on handling characteristics," said Dr Wolfgang Kranig of Schüchtermann-Schiller'sche Kliniken in Bad Rothenfelde, Germany. "Because of the benefits this quadripolar technology offers without any significant tradeoffs, it should be considered a new standard of care for CRT."
The Quartet left-ventricular pacing lead, used as part of the Promote Quadra system allows up to 10 pacing configurations. This allows the physician to implant the lead in the most stable position, while still being able to select the most optimal pacing location. It also allows more options in optimising CRT performance, such as pacing around scar tissue in the heart, and avoiding common pacing complications.
St Jude's new pacing lead features its Optim insulation - a material that combines the biostability and flexibility of high-performance silicone rubber with the strength, tear resistance and abrasion resistance of polyurethane, to provide increased durability, flexibility and improved handling characteristics - and the "S-curve" design of the QuickFlex lead family, which increases stability.
"Physicians no longer need to make a trade-off between positioning the lead in the most stable location and positioning the electrodes in the best pacing location," said Eric Fain, MD, president of the St. Jude Medical Cardiac Rhythm Management Division. The lead "also gives physicians more control over patient therapy by providing the flexibility to non-invasively adjust the pacing location or configuration to meet patient needs," he added.
Heart resynchronisation uses implantable cardioverter defibrillators (ICD) or pacemakers to resynchronise the beating of the lower chambers (ventricles), which often beat out of sync in heart failure patients.
St Jude's statement said that 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. About 23 million people worldwide are afflicted with congestive heart failure (CHF), and 2 million new cases of CHF are diagnosed each year worldwide.
Both the Promote Quadra CRT-D and Quartet pacing lead have gained European CE Mark approval, and are also currently under trial for exempt approval by the US Food and Drug Administration.
PIC: A St Jude ICD for cardiac resynchronisation therapy