MUNICH, Germany, May 19 /PRNewswire/ -- ELA Medical, a Sorin Group Company and innovative leader in the development of cardiac rhythm management (CRM) implantable and diagnostic systems, today announced the first European clinical implants of OVATIO(tm) CRT-D, its new cardiac resynchronization therapy defibrillator system.
The OVATIO CRT-D system is the first model in ELA's new OVATIO family of implantable cardioverter-defibrillators (ICDs) which also features a single chamber - OVATIO VR - and a dual chamber ICD model - OVATIO DR.
Like dual chamber OVATIO model, OVATIO CRT-D includes PARAD(R)+, the most specific ventricular arrhythmias detection software available to patients worldwide today. PARAD+ demonstrated a 99%[1] overall specificity in a study recently published.
PARAD+ is intended to protect heart failure patients from inappropriate shocks which may result from atrial fibrillation (AF), a common comorbidity of heart failure that affects about one third of all heart failure patients. PARAD+ has been shown to decrease the patient's individual risk of receiving inappropriate therapy due to AF to only 0.3 percent[2].
The first implant of OVATIO CRT-D occurred at the Heart Center North Rhine Westphalia, Ruhr University Bochum, in Bad Oeynhausen, one of Europe's largest ICD and CRT-D implant centers.
The device was implanted in a 78-year-old man with a history of ischemic cardiomyopathy due to coronary artery disease who underwent CABG in 1999 and replacement of the aortic valve in 2002, by cardiologist Dr. J. Vogt and cardiac surgeon Dr. B. Hansky in the Cardiology Department headed by University Professor D. Horstkotte and the Department of Cardio Thoracic Surgery, headed by University Professor R. Korfer.
Professor Dr. D. Horstkotte declared: 'The OVATIO CRT-D system is a refined combination of the most innovative defibrillation technologies. OVATIO CRT-D will enable us to manage our heart failure patients in the long term and treat them with tailored therapies. The well-established PARAD+ detection algorithm is a premium choice for HF patients who have a really poor heart condition because it delivers shocks only when strictly necessary.'
Other clinical implants of OVATIO CRT-D will also occur in France, Great Britain, Denmark and Netherlands. The OVATIO CRT-D received CE-mark certification on April 25, 2005.
The OVATIO CRT-D system includes biventricular pacing therapy to resynchronize the ventricles of heart failure patients and the capacity to deliver defibrillation. This device is indicated in patients with heart failure who might also be at risk for from Sudden Cardiac Death (SCD).
Sudden cardiac death is a sudden loss of heart function which is due most of the time to the abnormally rapid and/or chaotic activity of the lower chamber of the heart (ventricle) known as ventricular tachycardia (VT) or ventricular fibrillation (VF). According to AHA[3] statistics, in congestive heart failure people, SCD occurs six to nine times more often than in the general population.
OVATIO CRT-D provides flexible biventricular therapy programming, including V-V (ventricle to ventricle) timing. V-V timing allows physicians to separately adjust the timing of the electrical pulse delivered to the ventricles, as well as to choose which ventricle is paced first. Patients who do not respond to simultaneous biventricular pacing systems may benefit from the sequential timing offered by V-V programmability.
OVATIO CRT-D also incorporates new features dedicated to arrhythmia management and advanced diagnostic features.
Physiologically-shaped and long-lasting, the OVATIO CRT-D system can be used in conjunction with ELA's advanced left ventricular over-the-wire and stylet-driven SITUS(r) leads which can accommodate all venous anatomies. The SITUS(r) leads have gained wide acceptance with their ease of use, stability and unmatched performance.
'The introduction of OVATIO CRT-D is another illustration of the Sorin Group CRM's commitment to delivering optimal care to the heart failure patient. The OVATIO CRT-D has been designed to reduce inappropriate shocks and enhance the quality of life of patients while providing physicians with the most advanced diagnostic and therapeutic solution,' said Andre-Michel Ballester, president of the Sorin Group's CRM business unit.
The roll-out of the complete OVATIO ICD family is expected in the last quarter of 2005 together with ELA's new generation of defibrillation leads.
ELA Medical, a Sorin Group Company, designs and manufactures implantable pacemakers and ICDs, leads, Holter equipment and electrophysiology catheters and markets them in Europe, the U.S. and Japan.
The Sorin Group (Reuters code: SORN.MI), a world leader in the development of medical technologies for cardiac surgery, offers innovative therapies for cardiac rhythm management, interventional cardiology and the treatment of chronic kidney diseases. The companies of the Sorin Group are: Dideco, CarboMedics, COBE Cardiovascular, Stockert, Mitroflow, ELA Medical, Sorin Biomedica, Bellco and Soludia. The Sorin Group has about 4,750 employees working at facilities in more than 80 countries throughout the world to serve over 5,000 public and private treatment centers.
For more information please visit: www.sorin.com
References:
[1] Hintringer F. et al. Comparison of the Specificity of Implantable Dual Chamber Defibrillator Detection Algorithms. PACE, July 2004, vol. 27 p. 976-982
[2] Enhanced Specificity of a Dual Chamber ICD Arrhythmia Detection Algorithm by Rate Stability Criteria. R Mletzko, F Anselme, D Klug, W Schoels, R Bowes, N Iscolo, R Nitzsche, N Sadoul On behalf of the 'Slow VT Study' Investigators. PACE August 2004;27:1113-1119
[3] Heart Disease and Stroke Statistics - 2005 Update, American Heart Association.
