St. Jude Medical Earns CE Mark for CRT-D

On a roll with heart devices, St. Jude Medical has earned CE mark approval for its next-generation quadripolar device, the Quadra Assura MP cardiac resynchronization therapy defibrillator (CRT-D). Built upon the company’s Quadripolar Pacing System, the Quadra Assura MP CRT-D features MultiPoint Pacing (MPP) technology that enables physicians to pace multiple locations on the left side of the heart. This gives the clinician more choices to best optimize cardiac resynchronization therapy (CRT) pacing to meet individual patient needs.

The Quadra Assura MP CRT-D is designed to work with the Quartet lead, which has four electrodes meant to offer maximum flexibility for different pacing configurations. The new MPP capability reportedly allows physicians to program simultaneous or sequential delivery of two left-ventricular (LV) pulses per pacing cycle, rather than the standard single pacing pulse. The capability to deliver two LV pulses per cycle allows physicians to tailor CRT pacing for each patient, potentially leading to more effective outcomes compared to single site pacing, which may be particularly beneficial in patients not responding to traditional bi-ventricular pacing therapy.

“Many patients with heart failure have scar tissue on their cardiac anatomy that makes it difficult to provide them with optimal and effective therapy,” said Carlo Pappone, M.D., Ph.D., director of the department of arrhythmology at Maria Cecilia Hospital, GVM Care & Research in Cotignola, Italy. “The new MultiPoint Pacing technology helps individualize therapy for each of my patients and potentially allows those patients unable to benefit from traditional cardiac resynchronization therapy to be effectively treated.”

CRT pacing can be delivered by an implantable cardioverter defibrillator (ICD) to resynchronize the beating of the heart’s lower chambers (ventricles) that often beat out of sync in heart failure patients. National Institutes of Health studies show that CRT can improve the quality of life for many patients with heart failure, a progressive condition where the heart weakens and loses its ability to pump an adequate supply of blood. Currently, approximately 14 million people in Europe have heart failure and this number is rising, according to heartfailurematters.org.

“Quadripolar pacing has become the standard of care for many physicians,” said Eric Fain, president of the St. Jude Medical Implantable Electronic Systems division. “We are pleased to continue our innovation by offering the industry’s first MultiPoint Pacing system, which provides a new set of non-invasive tools to address patients who are non-responders to traditional CRT pacing, potentially decreasing heart failure hospitalizations and lowering the economic burden.”

Preliminary results from a study presented at this year’s Heart Rhythm Society scientific sessions showed that after three months, 89 percent of patients treated with the St. Jude Medical MPP were classified as responders, an increase of nearly 20 percent. On average, the response rate to traditional CRT is approximately 70 percent.

St. Jude Medical is based in St. Paul, Minn., and makes medical technology in a range of segments including cardiovascular.