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Studies Show Benefits of Medtronic SmartShock(TM) Technology and Physician Reports in Protecting Patients from Inappropriate Shocks

PR-Inside.com: 2015-01-29 15:33:02
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 SmartShock(TM) 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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Source: Medtronic plc via GlobeNewswire
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