Sorin Group Announces FDA Approval of the World?s Smallest Cardiac Resynchronization Implantable Cardioverter Defibrillator: OVATIO? CRT
The Sorin Group (MIL:SRN), the largest European cardiovascular company
and world leader in medical technologies for cardiac surgery, announces
the U.S. Food and Drug Administration´s (FDA)
approval to market the CRT model of its OVATIOâ„¢ family. Coupled together with the Situsâ„¢ OTW
left ventricle pacing lead, this device will now allow US physicians to
treat their heart failure patients with a complete Sorin Group system.
OVATIOâ„¢ CRT 6750, the smallest CRT
defibrillator (CRT-D) available worldwide (30cc, 11mm) is shaped to
offer ease of implantation and long-term patient comfort, and is
designed to allow more flexibility in the management of cardiac
resynchronization and anti-tachyarrhythmia therapy, thanks to a unique
feature: Brady-Tachy Overlap (BTO).
Maintaining CRT during exercise, including at elevated heart rates
might allow the patient to experience prolonged, and eventually
beneficial physical activity1. However heart
failure patients present a high incidence of "slow" ventricular tachycardias (VT) which heart rates coincide with exercise
rates2. These arrhythmias have been reported to
cause significant clinical effects3. Managing
these conflicting aspects is challenging and usually either CRT delivery
has to be favoured at the expense of slow VTs protection, or inversely.
OVATIOâ„¢ CRT´s BTO
feature is designed to "Unlock Pacing and
Detection", to ensure delivery of
resynchronization therapy during exercise without any compromise on the
management of slow VTs.
"I like the fact that with the smallest CRT-D
in the world I can resynchronize my patients during maximal exercise as
well as detect and treat slower ventricular tachycardias without
programming constraints", stated Dr Michael
R. Gold, Medical University of South Carolina, Charleston, South
Carolina (USA).
Moreover, OVATIOâ„¢ CRT performs best-in-class
detection of arrhythmia thanks to P And R Arrhythmia Detection (PARAD®/PARAD®+).
Studies demonstrated that PARAD+ has a superior specificity in
discriminating atrial from ventricular arrhythmias: the absolute risk of
experiencing an inappropriate shock has been observed to be only 5%, the
lowest percentage reported thus far4. For heart
failure patients it is crucial that life saving therapies are delivered
when necessary, and only when necessary, to improve quality of life.
"The OVATIOâ„¢ CRT-D system completes the
range of Sorin Group defibrillators available in the US, in addition to
OVATIOâ„¢ single- and dual-chamber
defibrillators and to the ISOLINEâ„¢ defibrillation lead. It is a big step towards strengthening our position
in the US by entering the $ 2 billion CRT segment and offering a
complete solution to patients and physicians"
said Fred Hrkac, President of Sorin Group Cardiac Rhythm Management
(CRM) Business Unit.
The OVATIOâ„¢ CRT will be distributed in the
United States by ELA Medical, Inc., a Sorin Group Company.
About heart failure and resynchronization
With 550,000 new cases diagnosed annually in the United States, heart
failure is the most costly cardiovascular disease. Approximately $40
billion are dedicated annually to the treatment of this debilitating
condition, which affects 5 million5 Americans.
Cardiac Resynchronization Therapy Defibrillators are indicated in heart
failure patients who might be at risk for Sudden Cardiac Death (SCD).
CRT-D devices are capable of restoring a better coordination of the
heartbeats, which has been proven to improve quality of life, increase
exercise capacity, and reduce hospitalizations and mortality in these
patients. CRT-D devices also provide patients with anti-tachyarrhythmia
therapies when abnormally fast, life-threatening rhythms occur.
About the Sorin Group
The Sorin Group (Bloomberg: SRN.IM; Reuters: 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. The Sorin Group
includes these brands: Dideco, CarboMedics, COBE Cardiovascular, Stöckert
Mitroflow, ELA Medical, Sorin Biomedica, Bellco and Bellco-Soludia. At
the Sorin Group 4,500 employees work to serve over 5,000 public and
private treatment centers in more than 80 countries throughout the world.
For more information, please visit: www.sorin.com or www.sorin-crm.com.
1 Auricchio, A., et al. Exercise Performance
Following Cardiac Resynchronization Therapy In Patients With Heart
Failure and Ventricular Conduction Delay. The American Journal of
Cardiology, Vol. 89 January 15, 2002
2 Data on file extracted from N Sadoul, R
Mletzko, F Anselme, for the Slow VT Study Group Incidence and Clinical
Relevance of Slow Ventricular Tachycardia in Implantable
Cardioverter-Defibrillator Recipients: Circulation 2005; 112: 946-53
3 Bansch D et al. Ventricular tachycardias
above the initially programmed tachycardia detection interval in
patients with implantable cardioverter-defibrillators: incidence
prediction and significance. J Am Coll Cardiol. 2000 Aug;36(2):557-65.
4 AnselmeF et al: Prevention of Inappropriate
shocks in ICD Recipients: A review of 10000 Tachycardia Episodes. PACE
Vol 30, January 2007, Supplement 1
5 Circulation "“ Journal of the American Association "“ ACC/AHA
2005 Guideline Update for the Diagnosis and Management of Chronic Heart
Failure in the Adult "“ Summary Article "“ p. 1826