CE Mark for World’s Only MultiPoint Pacing Pacemaker

St. Jude Medical, Inc. has gained CE Mark approval of the Quadra Allure MP™ cardiac resynchronization therapy pacemaker (CRT-P).

Background

MultiPoint Pacing technology enables physicians to pace multiple locations on the left side of the heart, giving the clinician more choices to optimize CRT pacing based on patient need. The aim is to reduce the rate of CRT non-responders, as well as the likelihood of costly and invasive lead revision through a second intervention procedure.

St.Jude’s Quadra Allure MP is the world’s first and only quadripolar CRT-P with the MultiPoint Pacing option, which a recent study suggests may be particularly beneficial in patients not responding to traditional bi-ventricular pacing therapy. Compared with traditional methods of CRT, MultiPoint Pacing has demonstrated a 19 percent improvement in responder rates at 12 months . Additionally, research found improvement in left-ventricular (LV) function in patients who were already classified as a responder to CRT therapy.

The system is designed to work with the Quartet™ LV lead, which has four electrodes to offer maximum flexibility for different pacing configurations to help manage heart failure patients. The MultiPoint Pacing capability allows physicians to program simultaneous or sequential delivery of two LV pulses at two different anatomical locations per pacing cycle, rather than the standard single pacing pulse, which can result in more effective resynchronization, potentially leading to better clinical outcomes compared to single site pacing.

The news of this system’s CE mark follows the presentation of data during the XVI International Symposium on Progress in Clinical Pacing in Rome December 2 – 5, 2014. Again results showed that MultiPoint Pacing improved LV function for both responders and non-responders compared to traditional CRT.

Physician comments

“From our initial experience, we think MultiPoint Pacing improves cardiac function, resulting in better resynchronization and could be a further advantage of CRT,” said study investigator, Dr. Francesco Zanon, MD, FESC, FHRS, director of the Electrophysiology Unit Department of Cardiology from Santa Maria della Misericordia Hospital in Rovigo, Italy. “We observed significant improvement over traditional CRT pacing, and therefore believe this technology could have wide application because it is accessible for all CRT implanters.”

Company comments

“The St. Jude Medical quadripolar pacing system has been successfully designed for optimized outcomes, now adding MultiPoint Pacing as an additional set of tools designed to decrease the rate of non-responders and improve clinical outcomes even in difficult to treat patients with ischemic heart disease,” said Eric S. Fain, M.D., group president of St. Jude Medical. “Building upon the industry’s first quadripolar platform, the MultiPoint Pacing technology is an excellent example of our continued commitment to investing in innovative solutions that reduce health care costs and improve outcomes for patients.”

Source: St.Jude Medical, Inc., Business Wire

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