Sorin Group (MIL:SRN) Cardiac Rhythm Management announced today the
first implant in a clinical trial of its new-generation PARADYMâ„¢ 8770 sonRâ„¢1 cardiac
resynchronization therapy defibrillator (CRT-D). This system contains a
unique technology named sonRâ„¢designed to
adjust CRT delivery based on hemodynamic response as opposed to
conventional CRT-D devices, that monitor the electrical activity of the
heart. PARADYMâ„¢ sonRâ„¢ is the first device delivering continuous management of
resynchronization therapy during patients´ everyday life.
Previous clinical studies have shown that up to 25% of patients, who
meet the criteria for CRT and who are implanted with a CRT-D device do
not benefit from the therapy. Studies suggest that, in order to improve
therapy success rate2, it is important to offer
each patient a tailor-made programming of the timing between electrical
impulses sent to different parts of the heart (CRT settings). Manual
programming of CRT settings can be guided using echocardiography, but
echo optimization is not applied for all patients because it is a
time-consuming and non-standardized procedure. Moreover, patient status
can change over time, due to many factors (modifications of drug
regimen, life-style changes, and modification of heart dimension). It is
therefore crucial to re-assess and re-adjust the CRT settings on a
regular basis.
Fred Hrkac, President of Sorin Group Cardiac Rhythm Management (CRM)
Business Unit commented: "The sonRâ„¢ sensor is one of our most promising innovations in the treatment of
heart failure because it allows to automatically re-adjust the CRT
settings. Whereas conventional devices look at the heart as a "clock"
new PARADYMâ„¢ sonRâ„¢ looks at the heart as a "pump"
measuring vibrations generated by heart contraction. Thanks to this
innovative approach, we provide the medical community and their patients
with a completely new system, and this is in line with our vision to
become an innovative leader in hemodynamic management of heart failure".
The new PARADYMâ„¢ device with its sonRâ„¢ functionality is designed to measure and evaluate the performance of the
cardiac pump, and to adapt the CRT settings to the patients´ cardiac status automatically and recurrently during patients´ everyday life.
A multi-centre clinical trial including 150 patients is currently being
conducted across Europe. The first sonRâ„¢ systems, the PARADYMâ„¢ sonRâ„¢ CRT-D, including the sonRâ„¢ FIX atrial lead
were implanted by Prof. Angelo Auricchio from Cardiocentro Ticino in
Lugano, Switzerland, Dr Peter Paul Delnoy from Isala Clinics in Zwolle
Netherlands, and Dr Neil Sulke from Eastbourne General Hospital in the
United Kingdom.
Dr Peter Paul Delnoy declared: "Optimal
resynchronization of the ventricles in heart failure patients is crucial
for the success of the therapy. With the new sonRâ„¢ sensor, the device is designed to adjust CRT settings for each patient
recurrently during daily life including both rest and exercise."
The PARADYMâ„¢ family also includes a
single-chamber (VR 8250), and a dual-chamber (DR 8550) implantable
cardioverter defibrillator for the management of arrhythmias.
"I´m excited about
the comprehensive range of therapeutic tools that PARADYMâ„¢ DR offers. I like the small profile and the high energy output (42J)
which provides extra safety margin for patients with high defibrillation
thresholds. That, coupled with SafeRâ„¢ to
reduce unnecessary ventricular pacing and PARAD+â„¢ to reduce inappropriate shocks, makes this an ideal ICD for my patients"
said Dr Franck Krümel from the Herz-und Gefässzentrum
Bad Bevensen, Germany, primary investigator of the PARADYMâ„¢ Clinical Release study, who implanted the first PARADYMâ„¢ DR.
About heart failure and resynchronization therapy
According to the European Society of Cardiology (ESC) and the American
Heart Association (AHA), more than 10 million3 Europeans and 5 million4 Americans suffer from
heart failure, the most costly cardiovascular disease.
Cardiac resynchronization therapy defibrillators are indicated in
advanced heart failure patients who might be at risk for Sudden Cardiac
Death (SCD). CRT-D devices are capable of resynchronizing the
contractions of the ventricles (the heart´s lower chambers) by
delivering low-energy impulses to improve the pumping performance of the
heart. They also provide patients with defibrillation support when
abnormally fast, life-threatening heart 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.
1 Not available for distribution in the
United-States
2 Incremental benefit of Sequential vs
Simultaneous CRT - B. Van Gelder - Am J Cardiol 04
3 European Heart Journal "“ ESC Guidelines for the diagnosis and treatment of Chronic Heart Failure:
full text (update 2005) "“ p. 3
4 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
