St. Jude Medical receives CE Mark approval for Quadra Allure MP CRT-P

Quadra Allure MP™ CRT-P expands the St. Jude Medical heart failure portfolio and is supported by newly presented data that demonstrate an increase in patient response to multipoint pacing therapy

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced CE Mark approval of the Quadra Allure MP™ cardiac resynchronization therapy pacemaker (CRT-P). The Quadra Allure MP is the world’s first and only quadripolar CRT-P with the MultiPoint Pacing option, a technology that has been shown to enhance patients’ response to CRT, potentially improving quality of life for patients with heart failure. The MultiPoint Pacing technology enables physicians to pace multiple locations on the left side of the heart, giving the clinician more choices to best optimize CRT pacing based on patient need and reducing the rate of CRT non-responders, as well as the likelihood of costly and invasive lead revision through a second intervention procedure.

A recent study demonstrates that MultiPoint Pacing technology may be particularly beneficial in patients not responding to traditional bi-ventricular pacing therapy, which accounts for approximately one third of the total population of patients receiving cardiac resynchronization therapy (CRT). The technology, developed by St. Jude Medical, has demonstrated a 19 percent improvement in responder rates for patients with MultiPoint Pacing at 12 months compared to traditional methods of CRT. Additionally, research found improvement in left-ventricular (LV) function in patients who were already classified as a responder to CRT therapy.

The Quadra Allure MP CRT-P 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.

St. Jude Medical developed the quadripolar technology, launching the first ever quadripolar lead in 2011 and entered the pacemaker market in April 2013 with the Allure Quadra™ CRT-P System. Quadripolar technology offers physicians more options to manage heart failure and facilitates additional pacing configurations within the heart that offer physicians options not available in traditional bipolar systems. Earlier this year, the MORE-CRT prospective, randomized clinical trial of more than 1,000 patients demonstrated a 40 percent relative risk reduction of lead-related complications for patients implanted with the Quartet LV lead. To date, more than 100 clinical publications have provided broad clinical evidence supporting the advantages of quadripolar technology from St. Jude Medical.

Today’s announcement follows data that was presented during the XVI International Symposium on Progress in Clinical Pacing in Rome December 2 – 5, 2014. Building upon the 19 percent improved responder rate, data shows that MultiPoint Pacing improved LV function for both responders and non-responders compared to traditional CRT. Additionally, a study suggests that multipoint LV pacing may reduce the burden of premature ventricular contractions (PVC), potentially improving the effectiveness of CRT.

“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.”

“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.”

MultiPoint Pacing is an investigational device and is not commercially available in the U.S.