[May 08, 2012]

Sorin Group Announces FDA Approval and Commercial Launch of PARADYM(TM) RF ICDs and CRT-D Implantable Heart Devices

Sorin Group (News - Alert), (Reuters Code: SORN.MI), a global medical device company and a leader in the treatment of cardiovascular diseases, announced today at Heart Rhythm 2012, the Heart Rhythm Society's 33^rd Annual Scientific Sessions, FDA approval and commercial launch of the PARADYM™ RF family of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT-D) devices. These new heart devices, including the single-chamber PARADYM™ RF VR, the dual-chamber PARADYM™ RF DR and the PARADYM™ RF CRT-D, are designed to be monitored remotely.

The PARADYM™ RF family offers Sorin's powerful proprietary SafeR™ and Parad™+ algorithms that automatically adjust to each individual patient to minimize right ventricular (RV) pacing and inappropriate shocks. PARADYM™ devices are the only clinically proven ICDs that both reduce RV pacing below one percent^{1 2} and offer the lowest recorded inappropriate shock rate³ of any devices available to date.

The new devices are designed to provide patients with the optimal combination of thinness, high power and longevity. Utilizing state-of-the-art battery and capacitor technology, the PARADYM™ RF CRT-D and ICD devices deliver 37J of energy with longevity over 6 years⁴ and 9 years⁵ respectively in an 11mm thin device.

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 cardiac resynchronization therapy. In addition, PARADYM&tade; 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.

"The combination of features offered within the PARADYM™ RF devices will be appreciated by many U.S. physicians who treat patients at risk of sudden cardiac arrest, including some whose heart failure can be managed by cardiac resynchronization therapy," said Dr. Freddy Abi-Samra, M.D., Ochsner Medical Center, Louisiana, US.

Stefano Di Lullo, Sorin Group, President of the CRM Business Unit, commented: "We are pleased to extend our family of PARADYM™ devices for U.S. physicians and patients with the FDA approval of PARADYM RF and PARADYM RF CRT-D. The introduction of these new devices adds to Sorin's growing portfolio of innovative implantable heart therapies designed to save lives and improve patient symptoms."

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 3,750 employees worldwide, Sorin Group focuses on three major therapeutic areas: 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

¹ "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).

² With SafeR mode

³ 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

⁴ 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

⁵ 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

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