Studies Show Benefits of Medtronic SmartShock(TM) Technology and Physician Reports in Protecting Patients from Inappropriate ...
January 29 2015 - 9:30AM
New Results from PainFree SST, Shock-Less Studies,
Involving Nearly 7,000 Patients, Published in
HeartRhythm
DUBLIN and MINNEAPOLIS -
Jan. 29, 2015 - Medtronic plc (NYSE: MDT)
today announced new results from the PainFree SST and Shock-Less
clinical studies published in the journal HeartRhythm. The data show that treating patients with
Medtronic implantable cardiac devices equipped with
SmartShockTM Technology,
and that providing clinicians with proactive reports, help
physicians deliver lifesaving therapy while avoiding inappropriate
and unnecessary shocks.
The studies evaluated cardiac resynchronization
therapy-defibrillators (CRT-Ds) and implantable cardioverter
defibrillators (ICDs), which stop life-threatening fast or
irregular heartbeats by shocking or pacing the heart. While most
ICD-delivered shocks are needed, previous studies estimated that
approximately 20 percent of patients with ICDs may experience
inappropriate shocks in response to benign arrhythmias or
electrical noises sensed by their devices. The new PainFree
SST study results show that the rate of inappropriate shocks for
patients with the Medtronic SmartShock Technology was 1.5 percent
with a dual/triple chamber defibrillator and 2.5 percent for single
chamber ICD at one year after implant. At two years post-implant,
2.8 percent of dual/triple chamber and 3.7 percent of single
chamber device patients experienced inappropriate shocks.
These results are consistent with earlier findings
that showed 98 percent of patients with SmartShock technology are
inappropriate shock-free at one year.1
"The new results from PainFree SST reinforce that
SmartShock technology streamlines programming to help deliver
shocks only when necessary to save a life, and that ICD programming
truly matters in improving patient outcomes," said Angelo
Auricchio, M.D., Ph.D., FESC, Fondazione Cardiocentro Ticino,
Lugano, Switzerland.
While PainFree SST data show the benefits of
SmartShock Technology, the results from the Shock-Less clinical
study demonstrate the importance of programming devices to improve
"real world" patient outcomes. Most implanted ICDs are programmed
to the manufacturers' default settings; however, the Shock-Less
study showed that patients had better outcomes when their
clinicians received guideline-based programming recommendations and
periodic programming compliance reports prior to ICD implants.
Patients who received ICD implants after their clinicians received
these reports were up to 20 percent more likely to have their ICDs
programmed according to guidelines, and to have a lower risk of
inappropriate shocks. Based upon the results of these studies,
Medtronic modified the initial settings of its ICDs, thereby
simplifying programming for physicians and optimizing outcomes for
patients.
In addition to providing better patient care,
previous studies have shown that preventing inappropriate shocks
also can lower the rate of hospitalizations, resulting in cost
savings (Medtronic ADVANCE III Trial).2
"For decades, ICDs have proven effective in
treating dangerous heart rhythms that lead to sudden cardiac death,
and now new features and best-practice programming help physicians
further reduce the rate of unnecessary shocks in their patients,"
said Marshall Stanton, M.D., vice president and general manager of
the Tachycardia Business at Medtronic. "These innovations ensure
that shocks are delivered only when needed to save lives, offering
peace of mind for patients and physicians, and reducing costs to
the healthcare system."
About the Studies
PainFree SST is a prospective, multicenter study that enrolled
2,790 patients at 126 centers across the globe, all of whom
received a new device implant, system upgrade or generator
replacement. Patients were followed for up to four years, with
visits every six months.
Shock-Less is a prospective clinical study that
enrolled 4,131 primary- and secondary-prevention patients with ICDs
between 2009 and 2012 at 118 clinical sites. After first
enrollments in the trial, clinicians received reports that
displayed ICD parameter settings in relation to evidence-based
targets (including number of intervals to detect Ventricular
Fibrillation (VF), longest treatment interval, supraventricular
tachycardia (SVT) discriminators, Lead Integrity Alert(TM) and
anti-tachycardia pacing).
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.
About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin,
Ireland, 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 results.
-end-
1 Volosin KJ,
Exner DV, Wathen MS, Sherfesee L, Scinicariello AP, Gillberg JM.
Combining shock reduction strategies to enhance ICD therapy: a role
for computer modeling. J Cardiovasc Electrophysiol. 2011
Mar;22(3):280-9.
2 Proclemer A, Arenal A, Lunati M, Ferrer JB, Hersi A, Manotta L,
Gasparini M. Association of long vs standard detection intervals
for implantable cardioverter-defibrillators with hospitalizations
and costs. JAMA. 2014;312(5):555-7
Contacts:
Tracy McNulty
Public Relations
+1-763-526-2494
Jeff Warren
Investor Relations
+1-763-505-2696
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information contained therein.
Source: Medtronic plc via Globenewswire
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