Sorin Group Receives CE Mark Approval for PARADYM™ RF ICDS And CRT-D

May, 05 2011
Sorin Group Receives CE Mark Approval for PARADYM™ RF ICDS And CRT-D

Sorin’s family of remote monitoring enabled implantable cardioverter defibrillators and cardiac resynchronization devices provides therapy tailored to the needs of individual patients
 
SAN FRANCISCO, US,  May 5th, 2011–Sorin Group, (Reuters Code: SORN.MI), a global medical device company and a leader in the treatment of cardiovascular diseases, announced today at Heart Rhythm 2011, the Heart Rhythm Society’s 32nd Annual Scientific Sessions,the CE mark approval for the PARADYM™ RF[1]family of implantable cardiac defibrillators (ICDs) and cardiac resynchronization therapy devices (CRT-D). With their proprietary algorithms, SafeR™ and Parad+™, PARADYM™ RF remote monitoring-enabled ICDs and CRT-D automatically adjust to provide individualized, appropriate therapy in a thin, powerful, long-lasting device.
 
The PARADYM™ RF devices are designed to be monitored remotely with Sorin’s new, easy-to-use SMARTVIEW™ remote monitoring system.  The SMARTVIEW™ system provides daily monitoring and scheduled remote follow-up of patients’ device status providing convenience and peace of mind to physicians and patients. 
 
PARADYM RF™ CRT-D and ICDs are designed to provide patients with the optimal combination of thinness, high power and longevity.  Utilizing state-of-the-art battery and capacitor technology and an innovative remote monitoring design featuring high speed data transfer and monitor-initiated connection, the PARADYM™ RF CRT-D and ICD devices deliver 37J of energy with longevity over 6 years[2]and 9 years[3]respectively in an 11mm thin device.
 
The PARADYM™ RF family includes Sorin’s proprietary SafeR™ and Parad™+ algorithms that automatically adjust to each individual patient to minimize right ventricular pacing and inappropriate shocks.  
 
“Too many ICD patients receive inappropriate shocks and unnecessary RV pacing resulting in decreased quality of life and increased mortality risk for patients PARADYM™ devices are the only clinically proven ICDs that both reduce RV pacing below 1%[4][5]and offer the lowest recorded inappropriate shock rate[6]on the market to date,” said Professor Brachmann from the Department of Cardiology at Klinikum Coburg (Germany), the first institution to implant the PARADYM™ RF CRT-D.
 
The PARADYM™ RF CRT-D also features a new programming option to electronically reprogram the device to avoid phrenic nerve stimulation, a common side effect of resynchronization therapy.  In addition, PARADYM™ RF CRT-Ds include Sorin’s exclusive Brady-Tachy Overlap (BTO™) algorithm that provides pacing therapy during exercise while maintaining the ability to detect and treat slow ventricular arrhythmias.  “We are impressed with the abilities of the new device” said Professor Brachmann.  “With BTO™ programming, we are able to encourage our heart failure patients to follow their cardiac rehabilitation program after CRT-D implant”.
 
Stefano Di Lullo, Sorin Group, President of the CRM Business Unit, commented: “Sorin Group is delighted to have obtained CE mark approval for the full PARADYM™ RF family. The introduction of these new remote monitoring enabled devices brings a wide range of treatment options for physicians but it is also consistent with our objective to provide best therapies and patient management solutions to patients and medical professionals”.
 
About Sorin Group
Sorin Group (www.sorin.com) is a global, medical device company and a leader in the treatment of cardiovascular diseases. The Company develops, manufactures, and markets medical technologies for cardiac surgery and for the treatment of cardiac rhythm disorders. With 3,700 employees worldwide, Sorin Group focuses on three major therapeutic areas that include: cardiopulmonary bypass (extracorporeal circulation and autotransfusion systems), cardiac rhythm management, and heart valve repair and replacement. Every year, over one million patients are treated with Sorin Group devices in more than 80 countries.
 
For more information, please visit: www.sorin.com, or contact:

 
Martine Konorski
Director, Corporate Communications
Tel: +33 (0)1 46 01 33 78
Mobile: +33 (0)6 76 12 67 73
e-mail: martine.konorski@sorin.com
 
 
 
Francesca Rambaudi
Manager, Investor Relations
Tel: +39 02 69969716
e-mail: investor.relations@sorin.com
 
 


[1]Investigational use only. Not available for distribution.
[2]Biventricular pacing in DDD mode, 1% in atrium, 100% in both ventricles, 500 Ohm, 3.5 V, 0.35 ms, 60 min-1, one 42 J shock per quarter, sensors OFF, remote monitoring: daily check, 4 remote follow-ups and 5 alerts with full reports per year
[3]Pacing in VVI mode 1%, 500 Ohm, 3.5 V, 0.35 ms, 60 min-1, one 42 J shock per quarter, sensors OFF, remote monitoring: daily check, 4 remote follow-ups and 5 full alert reports per year
[4]“AAIsafeR preserves ventricular activity in case of Paroxysmal AV Block while maintaining ventricular pacing below 0.1% in 28/35 (80%) of non-selected DDD patients” p. S246, Anselme, F., et al. First clinical results of AAIsafeR2,  a new mode to prevent ventricular pacing. Heart Rhythm 2005; 2, supp 5; p4-99 (abs).
[5]With SafeR mode
[6]Anselme, F., et al: Prevention of Inappropriate shocks in ICD Recipients: A review of 10000 Tachycardia Episodes. PACE, Vol 30, January 2007, Supplement 1. Study made using dual-chamber ICDs with standard dual-chamber arrhythmia classification algorithms