Sorin Group Cardiac Rhythm Management Announces CE Mark and First Implant of a New-Generation CRT-D Device Designed to Provide Hemodynamic Management of Heart Failure

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