St Jude Medical gains EU approval for high power ICD and CRT-D
9 February 2010
St Jude Medical, Inc. (NYSE:STJ) has announced European CE
Mark approval and first implants of its Fortify and Fortify ST
implantable cardioverter defibrillators (ICD) and Unify cardiac
resynchronization therapy defibrillator (CRT-D).
The devices will be fully launched in Europe later this spring, and US
versions of the Fortify ICD and Unify CRT-D are expected to be launched
later this year. The reduced size of these new devices compared to those
of previous generations creates the smallest available device footprint
in the industry.
The Fortify ICD and Unify CRT-D feature advanced battery technology
and circuitry that allow for a smaller device, with more energy capacity
and rapid charge times, all while increasing device longevity.
The energy capability of a device is particularly important for
patients who have an enlarged heart, low ejection-fraction, advanced
heart failure or previously demonstrated a high defibrillation threshold
(the amount of energy required to shock the heart back to a normal
These devices feature 40J of delivered energy (45J stored) helping to
ensure that therapy will be successful for those patients who require a
higher energy shock for defibrillation.
Because of the devices’ narrower shape, physicians can implant them
using a shorter incision, leading to less time spent closing the
incision and a smaller scar for the patient. The company’s SJ4 lead
connector system further streamlines the procedure by reducing the
number of connections between the defibrillation lead and the device,
which can improve patient comfort by reducing the bulk of wires in the
The Unify CRT-D and Fortify ICD also incorporate the new CorVue
pulmonary congestion monitoring algorithm. This new feature alerts
physicians when a patient’s heart failure may be worsening, as evidenced
by changes in electrical signals that can be correlated to increased
congestion, or fluid retention, in the chest area. The algorithm
continuously monitors fluid retention in multiple vectors, providing an
accurate diagnostic and an alert designed to minimize false positives.
“These new devices have been designed to address many of the clinical
issues facing our customers, from enhanced patient safety, reduction of
inappropriate therapy and streamlined implant procedures, to improved
disease management of cardiac conditions,” said Eric S Fain, MD,
president of the St Jude Medical Cardiac Rhythm Management Division.
“Our goal with this product line is to address all these needs and do so
while reducing the size of the device without compromising on either
delivered energy or device longevity.”
Both devices also have features that are designed to assist in the
reduction of unnecessary shocks, including painless anti-tachycardia
pacing, which can be used for fast ventricular arrhythmias prior to or
while the device is preparing to deliver shock therapy, and other
enhanced technology for reducing inappropriate therapy.
“This new device platform provides a number of new features that will
help me to improve management of my patients with ICD and CRT-D devices,
while delivering new safety features on top of St Jude Medical’s already
reliable technology,” said Prof. Werner Jung of Schwarzwald-Baar Klinkum
in Villingen-Schweningen, Germany. “The combination of the devices’
smaller size and SJ4 connector system also streamlines the implant
procedure and makes the device more comfortable for my patients.”
In addition to the family-wide features of the Unify and Fortify
devices, the Fortify ST ICD features St Jude Medical’s first-to-market
ST segment monitoring diagnostic algorithm, which can add important
information to assist in medical decision making and accelerate patient
The Fortify ST ICD continuously monitors for specific changes in the
ST segment of the electrocardiogram that can indicate the onset of
serious conditions such as ischemia (which occurs when blood flow/oxygen
to the heart muscle is obstructed). Because many cardiac episodes are
transient in nature, the continuous ST monitoring capability available
in the Fortify ST ICD gives physicians more comprehensive information
over time compared to the standard electrocardiogram (ECG or EKG) that
would otherwise only be recorded in the physician’s office.
An ICD is an advanced implantable device that treats potentially
lethal, abnormally fast heart rhythms (ventricular tachycardias or
ventricular fibrillation), which often lead to sudden cardiac death
(SCD). Approximately 325,000 people per year in the U.S. die suddenly of
A CRT-D device resynchronizes the beating of the heart's lower
chambers (ventricles), which often beat out of sync in heart failure
patients, and provides back up treatment for SCD, which is a risk factor
associated with certain types of heart failure.
Studies have shown that CRT (cardiac resynchronization therapy) can
improve the quality of life for many patients with heart failure, a
progressive condition in which the heart weakens and loses its ability
to pump an adequate supply of blood. About 5 million Americans suffer
from heart failure, with 550,000 new cases diagnosed every year,
according to the American Heart Association.
The Unify CRT-D and Fortify ICD are pending approval by the US Food
and Drug Administration (FDA).