Sorin Group Announces First U.S. Implants of OVATIO DR Implantable Cardioverter Defibrillators; World's Smallest ICD Features New Technology that Prevents Unnecessary Right Ventricular Pacing

ELA Medical, part of Sorin Group (MIL:SRN), announced
the first U.S. implants of its OVATIO(TM) implantable cardioverter
defibrillator (ICD) family, which recently received U.S. Food and Drug
Administration (FDA) clearance. These implants were conducted by
Doctors Atul Prakash, Rodrigo Chan, and Louis Rechani on May 22, in
New Jersey, Arizona, and Florida respectively. At 29cc, OVATIO is the
world's smallest ICD. In addition, OVATIO dual-chamber model (DR)
contains multiple unique features including; AAIsafeR mode, which
prevents unnecessary right ventricular pacing, and PARAD+ (R), the
second-generation of PARAD which is an industry-best algorithm for
minimizing inappropriate shocks.
In conjunction with the first implants of OVATIO ICDs, ELA Medical
is planning a nationwide awareness campaign for their innovative
AAIsafeR technology that could spare ten thousands of patient
hospitalizations for heart failure. The campaign is aimed at educating
U.S. doctors on the patient risks involved in unnecessarily pacing the
right ventricle in pacemaker and defibrillator recipients.
"OVATIO DR offers many unique features including small size, high
output, high specificity of the PARAD+ feature, and the AAIsafeR
algorithm. Many doctors may not be sufficiently aware of the fact that
unnecessary ventricular pacing increases the risk of congestive heart
failure and atrial fibrillation," said Dr. Atul Prakash, MD,
Electrophysiologist and Director of Arrhythmia services, UMDNJ,
Newark, NJ. "Both atrial fibrillation and heart failure affect patient
mortality. Treatment of these conditions also imposes a heavy
financial burden on the healthcare system. Limiting their incidence
through the use of available technology should be a priority for both
physicians and hospital administration."
Modern ICDs contain pacing functions that are designed to protect
patients when the normal conduction system in the heart fails. Drugs
that are used to control potentially lethal arrhythmias may also slow
down the patient's normal heart rate or prevent conduction from the
upper to the lower chambers of the heart.
Even ICD patients who rarely or never need ventricular pacing can
expect to be paced a high percentage of the time with conventional
pacing technology.
In response, ELA Medical developed a unique pacing mode for
promoting the patient's natural electrical conduction from the atria
to the ventricles. This mode, AAIsafeR, reduced ventricular pacing to
only 0.2% in OVATIO DR patients with intact conduction.(1)
AAIsafeR is the innovative algorithm that reduces unnecessary
right ventricular pacing and is the only mode that manages all three
types of heart block (first, second and third degree).
PARAD+, another unique feature, enables OVATIO DR to discriminate
Supraventricular tachycardia (SVT) from Ventricular Tachycardia (VT)
down to heart rates of 100 bpm and treat any ventricular arrhythmias
with anti-tachycardia pacing (ATP) in all zones, providing this as
first-line therapy saves patients from unnecessary shocks that may
traumatize them as well as reduce device longevity.
"Besides being the easiest and quickest ICD that I've ever
implanted, I'm extremely excited about the full package that OVATIO DR
offers" said Dr. Rodrigo Chan, MD, Electrophysiologist at Banner
Baywood Heart Hospital in Arizona. "I like the small profile and the
34J of maximum output that provides an extra safety margin for
patients with high defibrillation thresholds. That, coupled with
AAIsafeR makes this an ideal device for my patients."

ELA Medical:

ELA Medical, part of Sorin Group, designs and manufactures
implantable pacemakers and ICDs, leads, and Holter equipment and
markets them in Europe, the U.S. and Japan.

Sorin Group:

Sorin Group (Reuters code: SORN.MI), a world leader in the
development of medical technologies for cardiac surgery, offers
innovative therapies for cardiac rhythm dysfunctions, interventional
cardiology and the treatment of chronic kidney diseases. Sorin Group
includes: Dideco, CarboMedics, COBE Cardiovascular, Stockert,
Mitroflow, ELA Medical, Sorin Biomedica, Bellco and Soludia. Sorin
Group has more than 4,700 employees working at facilities in more than
80 countries throughout the world to serve over 5,000 public and
private treatment centers. www.sorin.com

REFERENCES

(1). Sorin Group - ELA Medical, clinical study, data on file