Sorin Group Announces European Launch of REPLY CRT-P, the World’s Smallest Cardiac Resynchronization Pacemaker

Sorin Group (MIL:SRN) (Reuters Code: SORN.MI), a global medical device company and a leader in the treatment of cardiovascular diseases, announced today the launch of REPLY CRT-P, its new cardiac resynchronization therapy pacemaker.

The REPLY CRT-P with its 11.3 cc in volume is the smallest cardiac resynchronization pacemaker in the world.

It features proprietary algorithms aimed at better supporting heart failure management and ultimately improving patient outcome.¹

The Sleep Apnea Monitoring (SAM) algorithm detects severe sleep apnea using a highly reliable sensor that measures ventilation. The index reported by the device has been validated against polysomnography, the gold standard method used to diagnose sleep apnea, yielding a high specificity of 85% and a sensitivity of 89%.²

Data from HF population studies suggest that both obstructive sleep apnea as well as central sleep apnea may be present in 30% to 50% of HF patients³. If left untreated, sleep apnea increases the risk of death and HF hospitalization^4,5,6. SAM can screen these patients for severe sleep apnea so that they can be treated. In addition, it can be used to monitor the long term progression of the disease.

Reply CRT-P also features Sorin’s dual sensor technology which is designed to enable a physiologic adaptation of the heart rate during exercise¹. In contrast to single sensors, the dual sensor responds to the metabolic demand of the body via the minute ventilation sensor and avoids any inappropriate reaction from the accelerometer thanks to its cross-checking technology. As a result, Reply CRT-P ensures optimal conditions for exercise training which is recommended for HF patients as it allows for maximal benefit of CRT^7,8.

The first REPLY CRT-P was implanted by Dr. Brian Gordon at Papworth Hospital in Cambridge, UK. The patient was a 72-year-old female with dilated cardiomyopathy. "The small size of the device is very impressive” said Dr. Gordon. "Size is an extremely important consideration for many patients alongside battery longevity and Reply CRT-P is setting the standard for the former without compromising the latter.”

"Sorin Group is dedicated to developing solutions for heart failure that enable optimal management of comorbidities such as sleep apnea.” said Stefano Di Lullo, President, Cardiac Rhythm Management business unit. "REPLY CRT-P is another example of this, providing state-of-the-art cardiac resynchronization therapy for HF patients while at the same time enabling the intuitive screening and monitoring of sleep apnea.”

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 3,900 employees worldwide,Sorin Group focuses on two major therapeutic areas: Cardiac Surgery (cardiopulmonary products for open heart surgery and heart valve repair or replacement prostheses) and Cardiac Rhythm Management (pacemakers, defibrillators and non invasive monitoring to diagnose arrhythmias and deliver anti-arrhythmia therapies as well as cardiac resynchronization devices for heart failure treatment) Every year, over one million patients are treated with Sorin Group devices in more than 100 countries.

For more information, please visit www.sorin.com.

References :

1. Sorin REPLY CRT-P implant manual (U636 REPLYCRT-P) available at www.sorinmanuals.com.

2. Defaye P et al. Heart Rhythm 2014; 11(5):842-8.

3. Javaheri S et al. Am J Respir Crit Care Med. 2011; 183(4):539-46.

4. Costanzo MR et al. JACC 2015; 65(1):72-84.

5. Lee W et al. Expert Rev Respir Med. 2008 June 1; 2(3):349–364.

6. Gottlieb DJ et al. Circulation 2010 July 27; 122(4):352-360.

7. Patwala AY et al. JACC 2009; 53(25):2332-9.

8. Tse et al. JACC 2005; 46(12):2292-7.

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