2013-05-10 21:33:02 -
"Shock-Less" Late Breaking Clinical Trial: Providing Clinicians with ICD
Programming Reports Improves Adherence to Evidence-Based Guidelines, Reduces
PainFree SST Trial: More Than 98 Percent of Patients with SmartShock(TM)
Technology Are Free of Inappropriate Shock at One Year
ADVANCE III Trial: Waiting to Deliver ICD Therapy Combined with ATP During
Charging(TM) Reduces the Rate of Inappropriate Shocks by 45 Percent and Reduces
Rate of Hospitalization by 19 Percent
MINNEAPOLIS and DENVER - May 10, 2013 -Validating its leadership in shock
reduction research and technology, Medtronic, Inc. (NYSE: MDT) today announced
the results of three clinical trials, Shock-Less, PainFree SST and ADVANCE III,
which successfully employed key strategies to dramatically reduce inappropriate
and unnecessary shocks in patients with implantable cardiac defibrillators
(ICD). The studies followed more than 7,000 patients on six continents; results
presented today at Heart Rhythm 2013, the Heart Rhythm Society's 34(th)
Annual Scientific Sessions.
ICDs are sophisticated devices designed to provide lifesaving shocks or painless
pacing (anti-tachycardia pacing, or ATP) to stop life-threatening fast or
irregular heartbeats. While the majority of shocks delivered are necessary to
treat potentially fatal arrhythmias, studies estimate that approximately 20
percent of patients with implantable defibrillators may experience inappropriate
shocks in response to a benign arrhythmia or electrical noise sensed by the
device.(1) According to published literature, ICD shocks are associated with
increased anxiety for the patient, as well as increased healthcare
The studies presented today demonstrate that a combination of Medtronic-
exclusive device algorithms and evidence-based programming strategies allow
physicians to safely avoid unnecessary shocks and can reduce the number of
patients who receive an inappropriate shock to less than two percent per year.
Shock-Less: Improved Adherence to Guidelines Reduces Inappropriate Shocks
Presented as a late-breaking clinical trial, results of Shock-Less demonstrated
that in real-world practice, providing clinicians with reports that displayed
ICD parameter settings in relation to evidence-based targets improved adherence
to evidence-based shock reduction programming, which was associated with reduced
risk of ICD shocks. The reports increased adherence to guidelines by up to 20
percent and reduced the relative risk of a shock by 27 percent. The Shock-Less
prospective clinical trial enrolled 4,131 primary and secondary prevention ICD
patients between 2009 and 2012 at 118 clinical sites.
"The results of this study are clear: When clinicians followed the evidence-
based programming recommendations, the risk of all cause and inappropriate
shocks was reduced," said Marc Silver M.D., lead investigator and cardiologist
at WakeMed in Raleigh, N.C. "Establishing methods that improve and maintain
clinician adherence to guidelines is therefore crucial to reducing ICD patient
PainFree SST: SmartShock(TM) Technology Reduces Inappropriate Shocks
Primary results from the PainFree SST clinical trial demonstrated that treating
patients with ICDs featuring Medtronic's exclusive SmartShock(TM) technology
resulted in the delivery of life-saving shocks when needed to save lives, with
more than 98 percent of patients free from inappropriate shocks during the first
year of implant.
SmartShock Technology features six exclusive algorithms automatically "ON" that
recognize life-threatening arrhythmias and deliver therapeutic shocks when
appropriate(2), therefore improving patient quality of life.(3) PainFree SST is
a multi-center international prospective clinical trial; this analysis
encompassed 1,308 patients implanted with dual and triple chamber ICDs.
ADVANCE III: Prolonged Detection and ATP During Charging Reduce Hospitalizations
and Inappropriate Shocks
The Shock-Less and PainFree SST results build on the findings of the ADVANCE
III(4) (Avoid DeliVering TherApies for Non-sustained Arrhythmias in ICD PatiEnts
III) clinical trial, published in this week's edition of the Journal of the
American Medical Association, which demonstrated reduced rate of
hospitalizations by 19 percent when devices were programmed to wait longer to
deliver therapy to patients, compared to devices with standard programming.
ADVANCE III data presented at Heart Rhythm further identified that this
prolonged detection also reduced the rate of inappropriate shocks by 45 percent.
"These data show that ICD programming matters, but real world clinical practice
suggests that many ICDs are not currently programmed for optimal patient
outcomes. By combining best practice programming with proprietary shock
reduction technology, Medtronic has made it easier to achieve and sustain the
patient outcomes reported in clinical trials with minimal programming changes,"
said Marshall Stanton, M.D., vice president and general manager, Implantable
Defibrillator Business, Cardiac Rhythm Disease Management at Medtronic.
Medtronic has provided the broadest portfolio of scientific research focused on
shock reduction, supporting 16 major clinical trials involving more than 15,000
patients worldwide-more than any other device manufacturer. Medtronic pioneered
the use of ATP, and is the only company to offer ATP During Charging(TM), which
automatically uses pacing pulses to painlessly stop fast, dangerous heartbeats
while concurrently preparing to deliver a shock if needed, with no delay.
In collaboration with leading clinicians, researchers and scientists worldwide,
Medtronic offers the broadest range of innovative medical technology for the
interventional and surgical treatment of cardiovascular disease and cardiac
arrhythmias. The company strives to offer products and services that deliver
clinical and economic value to healthcare consumers and providers worldwide.
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global
leader in medical technology - alleviating pain, restoring health, and extending
life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as
those described in Medtronic's periodic reports on file with the Securities and
Exchange Commission. Actual results may differ materially from anticipated
(1 )Poole JE, Johnson GW, Hellkamp AS, et al. Prognostic importance of
defibrillator shocks in patients with heart failure. N Engl J Med. 2008 Sep
4;359(10):1009-17. doi: 10.1056/NEJMoa071098.
(2 )Volosin et. al. "Virtual ICD: A Model to Evaluate Shock Reduction
Strategies." Heart Rhythm. Vol. 7, N. 5, May supplement 2010. (PO3-125).
(3) Wathen MS, et al. Circulation. 2004; 110:2591-2596.
(4) JAMA. 2013;309(18):1903-1911.
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Source: Medtronic, Inc. via Thomson Reuters ONE