|[August 31, 2014]
Large-scale Study Confirms Growing Body of Clinical Evidence for the St. Jude Medical Quadripolar System
ST. PAUL, Minn. & BARCELONA, Spain --(Business Wire)--
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 (News - Alert) 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 thatour 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
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
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 (News - Alert) @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 (News - Alert), 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.
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