Large-scale Study Confirms Growing Body of Clinical Evidence for the St.
Jude Medical Quadripolar System
St. Jude Medical Quartet quadripolar lead performed better than bipolar leads
of any kind
ST. PAUL, Minn. & BARCELONA, Spain -- August 31, 2014
St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today
announced results from a large-scale, clinical study concluding that the St.
Jude Medical Quartet™ left-ventricular (LV) quadripolar lead provides more
options to effectively manage common pacing complications compared to systems
with bipolar leads.
The MORE-CRT data, More Options available with a quadripolar LV lead pRovidE
in clinic solutions to CRT challenges, was presented during a hot line
late-breaking session at the European Society of Cardiology Congress 2014 (ESC
2014). Results showed that complications occurred less frequently and were
managed more efficiently in patients who received the Quartet lead than in
patients who received bipolar electrode leads.
“The risk of LV lead-related events was more than 40 percent lower in patients
implanted with a Quartet CRT-D system relative to patients implanted with a
bipolar CRT-D system,” said Prof. Giuseppe Boriani, M.D., Ph.D., of the
Institute of Cardiology, University of Bologna, Italy, and the MORE-CRT
steering committee chairman. “The overall freedom from intraoperative and
post-operative LV lead-related events was significantly higher in quadripolar
CRT group versus bipolar CRT group. These data are very important in deciding
how we treat our patients going forward.”
More than 60 centers from 13 countries participated in this first randomized,
large-scale clinical study of more than 1,000 patients comparing the St. Jude
Medical Quartet lead to bipolar LV leads (one-third of bipolar leads were St.
Jude Medical and two-thirds were non-St. Jude Medical). The primary endpoint
of the study was freedom from intra- and post-operative LV lead-related events
at six months.
The Quartet lead was associated with a statistically significant increase in
freedom from combined LV lead-related events — 85.97 percent in patients
implanted with a Quartet lead compared to 76.86 percent in patients implanted
with a bipolar LV lead.
“The design of St. Jude Medical’s Quartet quadripolar technology is unique,”
said Dr. Mark D. Carlson, chief medical officer and vice president of global
clinical affairs for St. Jude Medical. “The MORE-CRT study confirms that our
quadripolar system has set the standard for the quadripolar pacing industry
and the study is a strong addition to the more than 100 publications showing
our technology improves outcomes and quality while reducing costs.”
The quadripolar pacing technology is important because failed implant rates in
heart failure (HF) patients receiving a cardiac resynchronization therapy
(CRT) system are significantly higher with bipolar LV pacing leads due to
anatomy (creating lead stability problems), phrenic nerve stimulation (PNS) or
poor electrical measurements.
Leading Quadripolar Technology and Clinical Evidence
Additional data on the first-to-market MultiPoint pacing system presented
during ESC 2014 includes 12 month results from the St. Jude Medical
MultiPoint™ Pacing (MPP) clinical study. Twelve month results, consistent with
the three month data, indicates a 19 percent increase in the number of
patients responding to CRT compared to the standard-of-care, biventricular
pacing. CRT response in the MultiPoint pacing study was quantified as a
greater than 15 percent reduction in End Systolic Volume (ESV) and an increase
in ejection fraction (EF) to baseline, two commonly used but rigorous criteria
for determining CRT response. Quadra Assura MP™ CRT-D is an investigational
device in the U.S. and is not commercially approved in the U.S.
Data presented at the 2014 Heart Rhythm Society’s Annual Scientific Sessions
in May, Reduced Mortality with Quadripolar versus Bipolar Left Ventricular
Leads in Cardiac Resynchronization Therapy, demonstrates an 18 percent
reduction in mortality, as well as other improved clinical outcomes and better
cost utilization with St. Jude Medical’s quadripolar technology. The large and
growing body of clinical evidence combined with a strong product pipeline,
including next-generation MultiPoint pacing (investigational device in the
U.S.), makes St. Jude Medical’s quadripolar system the standard of care in
improving the management of CRT.
Data looking at Hospitalization Rates and Associated Cost Analysis of
Quadripolar versus Bipolar CRT-D: a comparative analysis of a single-center
prospective Italian registry, also presented at HRS 2014, found that the use
of quadripolar leads reduced the number of hospitalizations by 53 percent when
compared to the non-quadripolar leads. This hospitalization rate reduction
translated into a statistically significant 62 percent reduction in overall
costs for both health care systems and patients.
For more news from ESC 2014, visit esccardio.org.
About St. Jude Medical
St. Jude Medical is a global medical device manufacturer dedicated to
transforming the treatment of some of the world’s most expensive epidemic
diseases. The company does this by developing cost-effective medical
technologies that save and improve lives of patients around the world.
Headquartered in St. Paul, Minn., St. Jude Medical has four major clinical
focus areas that include cardiac rhythm management, atrial fibrillation,
cardiovascular and neuromodulation. For more information, please visit sjm.com
or follow us on Twitter @SJM_Media.
This news release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995 that involve risks and
uncertainties. Such forward-looking statements include the expectations, plans
and prospects for the Company, including potential clinical successes,
anticipated regulatory approvals and future product launches, and projected
revenues, margins, earnings and market shares. The statements made by the
Company are based upon management’s current expectations and are subject to
certain risks and uncertainties that could cause actual results to differ
materially from those described in the forward-looking statements. These risks
and uncertainties include market conditions and other factors beyond the
Company’s control and the risk factors and other cautionary statements
described in the Company’s filings with the SEC, including those described in
the Risk Factors and Cautionary Statements sections of the Company’s Annual
Report on Form 10-K for the fiscal year ended December 28, 2013 and Quarterly
Report on Form 10-Q for the fiscal quarter ended June 28, 2014. The Company
does not intend to update these statements and undertakes no duty to any
person to provide any such update under any circumstance.
St. Jude Medical, Inc.
J.C. Weigelt, 651-756-4347
Kristi Warner, 651-756-2085
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