Medtronic Announces European Launch of Protecta(TM) Portfolio With SmartShock(TM) Technology Shown to Significantly Reduce Inappropriate Shocks
By Medtronic Inc., PRNEWednesday, June 16, 2010
New Data Released at Cardiostim 2010 Shows Benefits of Advanced Shock Reduction Technologies
NICE, France, June 17, 2010 - Medtronic, Inc. (NYSE:MDT) 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 inappropriate
shocks:
- 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.
About Medtronic
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.
References: 1.Volosin et. al. "Virtual ICD: A Model to Evaluate Shock Reduction Strategies." Heart Rhythm. Vol. 7, N. 5, May supplement 2010. (PO3- 125). 2 American Cancer Society. Cancer Facts and Figures. 2006. 3 CIA. The World Fact Book - Rank Order - HIV/AIDS - deaths. Available at www.cia.gov. 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, 2004;350(21):2151-2158. 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.
Contacts: Yvan Deurbroeck, Public Relations (Europe), +41-21-802-7574; Jeff Warren, Investor Relations, +1-763-505-2696
Tags: France, June 17, Medtronic Inc., Nice