Nice, France, June 17, 2010 (ots/PRNewswire)
- Medtronic, Inc. today
announced European launch of the Protecta(TM) portfolio of
implantable cardioverter-defibrillators (ICDs) and cardiac
resynchronization therapy-defibrillators (CRT-Ds). The implantable
defibrillators feature Medtronic-exclusive SmartShock(TM) Technology,
comprised of six advanced shock-reduction algorithms that can
significantly reduce inappropriate shocks. Findings from the Virtual
ICD study statistical model predicted 98 percent of studied patients
with SmartShock Technology would be free of inappropriate shocks one
year after implant and 92 percent at five years post-implant(1).
These data were presented at Cardiostim 2010, the 17th World
Congress in Cardiac Electrophysiology and Cardiac Techniques.
"Reducing inappropriate shocks is a top priority for physicians,
which in turn can help improve the quality of life for implantable
defibrillator patients," said Angelo Auricchio, Ph.D., professor with
Cardiocentro Ticino in Lugano, Switzerland. "This advanced technology
will give my patients peace of mind that their device is designed to
recognize life-threatening arrhythmias and deliver life-saving shock
therapy only when needed to save their life."
ICDs and CRT-Ds are designed to provide painless pacing or
life-saving shock therapy to stop fast or irregular heartbeats, also
known as ventricular arrhythmias, which can lead to sudden cardiac
death. Sudden cardiac death kills more people each year than lung
cancer, breast cancer and HIV/AIDS combined(2,3). Medtronic estimates
that more than 70,000 lives have been saved worldwide by implantable
defibrillators during the last five years.
While the majority of life-saving shocks are appropriate, studies
estimate that approximately 20 percent of patients with implantable
defibrillators may experience inappropriate shocks within about three
years of implant in response to a non-lethal arrhythmia or electrical
noise within the device system(4 5). New Medtronic data released at
Cardiostim from the Managed Ventricular Pacing (MVP) trial show that
24 percent of patients who received painless anti-tachycardia pacing
(ATP) to terminate a potentially life-threatening arrhythmia visited
the hospital, clinic or emergency room at least once within three
days of receiving therapy, versus 56 percent of patients who were
treated with appropriate shock therapy, and 61 percent of patients
who received an inappropriate shock. This shows shock therapy may
correlate with greater health care utilization as compared to ATP.
Additionally, new data released on SmartShock Technology showed
lead fracture and T-wave oversensing algorithms can be safely applied
without delaying detection of life-threatening arrhythmias.
"By delivering ATP and only life-saving shocks, Protecta devices
with SmartShock Technology are sparing patients unnecessary worry and
have the potential to reduce the burden on the health care system,"
said Alain Coudray, M.D., Medtronic's vice president of the Cardiac
Rhythm Disease Management business in Europe. "This portfolio of
devices builds upon Medtronic's 20 years of leadership delivering
shock reduction technologies and evidence."
Medtronic has supported seven major shock reduction clinical
trials (Shock-Less, PREPARE, PainFree Rx I and II, WAVE, ADVANCE III
and EMPIRIC). In total, these trials provide data from more than
5,500 patients worldwide-more than any other device manufacturer.
About Protecta with SmartShock Technology
The Protecta implantable defibrillators include SmartShock
Technology, which features six new Medtronic-exclusive solutions that
are all pre-programmed and on when the device is implanted to address
- Three solutions (Wavelet + PR Logic, SVT discrimination in the VF zone,
and Confirmation +) in Protecta devices are designed to discriminate
between different non-lethal and lethal arrhythmias to provide
lifesaving shock therapy only when necessary.
- T-wave Discrimination and Lead Noise Discrimination features are
designed to distinguish between deadly arrhythmias and oversensing to
withhold shock therapy when appropriate.
- Lead Integrity Alert, first released in 2008, provides advanced warning
of potential lead fractures so the patient can seek medical attention,
and reduces the risk of receiving an inappropriate shock.
Medtronic received CE (Conformite Europeenne) Mark for the
Protecta portfolio in March. Within the Protecta family of devices,
Protecta XT devices have OptiVol(R) Fluid Status Monitoring, a
Medtronic-exclusive feature that measures changes in fluid build-up
in heart failure patients to predict worsening heart failure(6).
OptiVol 2.0, new on Protecta XT devices, improves the accuracy in
predicting when medical attention is needed(7). Medtronic implantable
defibrillators have Conexus(R) Wireless Telemetry that allows
patients to transmit device data to a physician's clinic from
virtually anywhere via the industry's largest remote monitoring
system, the Medtronic CareLink(R) Network. CareLink serves more than
4,000 clinics and 500,000 patients enrolled in 30 countries.
Note: The Protecta portfolio of devices is not available for sale
in the United States.
Medtronic, Inc. (http://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.
1.Volosin et. al. "Virtual ICD: A Model to Evaluate Shock Reduction
Strategies." Heart Rhythm. Vol. 7, N. 5, May supplement 2010. (PO3-
2 American Cancer Society. Cancer Facts and Figures. 2006.
3 CIA. The World Fact Book - Rank Order - HIV/AIDS - deaths. Available at
4 Kadish A, Dyer A, Daubert JP, et al, for the Defibrillators in Non-
Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE)
Investigators. Prophylactic defibrillator implantation in patients with
nonischemic dilated cardiomyopathy. N Engl J Med. May 20,
5 Poole, JE, et al. Prognostic Importance of Defibrillator Shocks in
Patients with Heart Failure. N Engl J Med 2008;359:1009-17.
6 Abraham WT, Compton S, Haas G, Foreman B, Canby RC, Fishel R, McRae S,
Toledo GB, Sarkar S, Superior Performance of Intrathoracic Impedance-
Derived fluid Index versus Daily Weight monitoring in Heart Failure
Patients: Results of the Fluid Accumulation Status Trial (FAST) J Card
Fail. Nov. 2009 Vol. 15(9): 813.
7 Hettrick DH, Sarkar S, Abraham WT, et al. Improved algorithm to detect
worsening heart failure via intrathoracic impedance monitoring in
patients with implantable devices. ACC Scientific Session, March 2010.
ots Originaltext: Medtronic GmbH
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