Assura devices feature three new algorithms, more power and extended
ST. PAUL, Minn.--(BUSINESS WIRE)--Nov. 28, 2012--
St. Jude Medical, Inc. (NYSE:STJ), a global medical device company,
today announced European CE Mark approval of the Assura™
portfolio of implantable cardioverter defibrillators (ICDs) and cardiac
resynchronization therapy defibrillators (CRT-Ds). The Assura family of
devices, featuring Shockguard™ technology has three new
algorithms that help protect patients against inappropriate shocks while
providing the highest amount of delivered energy. These improvements are
projected to reduce inappropriate therapy by 74 percent, allowing for
more effective therapy1. Products currently available in
Europe include the Quadra Assura™ CRT-D, Unify Assura™
CRT-D and Fortify Assura™ ICD.
ICDs are implantable cardiac devices that treat abnormally fast,
potentially lethal heart rhythms that can lead to sudden cardiac death
(SCD) if left untreated. A CRT-D device resynchronizes the beat of the
heart’s lower chambers, which often beat out of sync in heart failure
patients. A CRT-D also provides back up treatment for SCD, which is a
risk factor associated with certain types of heart failure.
All Assura devices can produce 40 Joules (J) of energy – the highest
delivered energy available. The devices include expanded ShockGuard
technology for protection against inappropriate and unnecessary shocks,
CorVue™ congestion monitoring and algorithms including
SecureSense™ RV lead noise discrimination, which offers
physicians advanced alerts and helps proactively lower the risk of
lead-related complications by automatically withholding tachycardia
therapy in the presence of lead noise (an over-sensing of electrical
The Fortify Assura device also offers enhanced ST
segment monitoring (which tracks electrical changes between
heartbeats). Monitoring of the ST segment helps indicate conditions such
as ischemia, which happens when blood flow and oxygen to the heart
muscle is obstructed. ST segment monitoring in an ICD prior to therapy
for ventricular arrhythmias can offer greater insight into the cause of
these dangerous heart rhythms.
“With the three new discriminators and highest amount of delivered
energy, the Assura devices provide the ideal combination of intelligence
and strength. These devices offer unique features that I believe will
help protect my patients from inappropriate shocks and provide greater
defibrillation therapy assurance,” said Dr. Klaus-Jürgen Gutleben, Heart
and Diabetes Center North Rhine-Westphalia in Bad Oeynhausen, Germany.
The three new Assura devices available in Europe are:
Assura CRT-D – Featuring first-to-market quadripolar pacing
technology from St. Jude Medical, the Quadra Assura CRT-D is designed
to address common pacing complications such as phrenic nerve
stimulation and high pacing thresholds, which can result in fewer
surgical revisions, shorter procedure times and decreased fluoroscopic
Assura CRT-D – Keeping the well-received shape of previous
generations of Unify™ devices, the Unifiy Assura CRT-D has
the smallest footprint in the industry for reduced incision size.
Assura ICD – Offering enhanced ST monitoring, the Fortify
Assura ICD also has the highest delivered energy of any ICD available.
While the majority of shocks delivered by ICDs and CRT-Ds are considered
appropriate and life-saving, the expanded ShockGuard technology,
included in all CE Mark approved Assura products, provides more accurate
sensing and can differentiate between rhythms that require
defibrillation and those that do not. The new algorithms and enhanced
detection capabilities discriminate between lead noise and arrhythmias
that require therapy, as well as which heart chamber is causing the
arrhythmia. The new algorithms also detect and alert to episodes of
oversensing due to lead noise and distinguish small electrical
disruptions from real episodes that warrant life-saving treatment.
The Assura family of devices allows for expanded ST segment monitoring
through the Merlin.net™
Patient Care Network, a system that allows patients to be monitored
from home. This system provides timely information to clinics and
ultimately allows for better management of patients with arrhythmias.
“St. Jude Medical understands patients’ needs vary, which is why we are
excited to add three new defibrillation technologies in Europe to our
complete portfolio of cardiac rhythm management devices,” said Eric S.
Fain, M.D., president of the St. Jude Medical Implantable Electronic
Systems Division. “The Assura line of devices was designed for safety,
reliability and extended longevity to help physicians best treat their
Across Europe, Sudden Cardiac Death (SCD) is estimated to affect between
180,000 and 450,000 people annually, according to meta-analysis
conducted by the Sudden
Cardiac Arrest Thought Leadership Alliance (SCATLA).
About St. Jude Medical
St. Jude Medical develops medical technology and services that focus on
putting more control into the hands of those who treat cardiac,
neurological and chronic pain patients worldwide. The company is
dedicated to advancing the practice of medicine by reducing risk
wherever possible and contributing to successful outcomes for every
patient. St. Jude Medical is headquartered in St. Paul, Minn. and has
four major focus areas that include: cardiac rhythm management, atrial
fibrillation, cardiovascular and neuromodulation. For more information,
please visit sjm.com.
This news release contains forward-looking statements within the meaning
of the Private Securities Litigation Reform Act of 1995 that involve
risks and uncertainties. Such forward-looking statements include the
expectations, plans and prospects for the Company, including potential
clinical successes, anticipated regulatory approvals and future product
launches, and projected revenues, margins, earnings and market shares.
The statements made by the Company are based upon management’s current
expectations and are subject to certain risks and uncertainties that
could cause actual results to differ materially from those described in
the forward-looking statements. These risks and uncertainties include
market conditions and other factors beyond the Company’s control and the
risk factors and other cautionary statements described in the Company’s
filings with the SEC, including those described in the Risk Factors and
Cautionary Statements sections of the Company’s Annual Report on Form
10-K for the fiscal year ended December 31, 2011 and Quarterly Report on
Form 10-Q for the fiscal quarter ended September 29, 2012. The Company
does not intend to update these statements and undertakes no duty to any
person to provide any such update under any circumstance.
1 Results based on stored electrogram clip testing. Data on
File, St. Jude Medical Test Reports, doc 60037875 and 60041229.
Reduction of inappropriate therapy is based upon a reduction in false
positive results and ATP set as the first therapy in all rate zones.
Source: St. Jude Medical, Inc.
St. Jude Medical, Inc.
Sarah Shamla, 651-756-6293