Sorin Group Announces the First Enrollment in the ISIS-ICD Clinical Study

Study will evaluate the effectiveness of PARAD+™ algorithm in minimizing inappropriate defibrillator shocks

Sorin Group, (Reuters Code: SORN.MI) (MIL:SRN), a global medical company and a leader in the treatment of cardiovascular diseases, announced today the first patient enrollment in its ISIS-ICD clinical trial. The primary objective of the study is to evaluate the percentage of patients implanted with an implantable cardioverter-defibrillator (ICD) featuring the Sorin PARAD+™ discrimination algorithm that are free from inappropriate ICD shocks over a one-year follow up. The first patient was enrolled by Mark Richards, PhD MD FACC, at The Toledo Hospital in Toledo, Ohio, USA.

"According to published literature, approximately 11 – 17% of ICD patients receive inappropriate shocks within one year after implant, negatively impacting patients’ health and quality of life,” said Dr. Richards, primary investigator for the ISIS-ICD study in the United States. "ICD shocks are painful and have been shown to increase anxiety and depression. In rare instances, they can also cause more dangerous arrhythmias. We expect the PARAD+ algorithm will markedly reduce the inappropriate shock rate by ensuring only harmful ventricular arrhythmias are treated. We are optimistic the ISIS-ICD trial will demonstrate this improved performance.”

ICDs help preserve life by terminating life-threatening heart irregularities with an electric shock to the heart. Measures to minimize the frequency of inappropriate shocks are important because they are painful, psychologically disturbing and potentially arrhythmogenic¹. The Sorin families of PARADYM and PARADYM RF defibrillators incorporate anti-shock features. A previous study has shown that Sorin’s PARAD/PARAD+ discrimination algorithms delivered the lowest rate of inappropriate shocks reported thus far, in a general ICD population.²

This multi-year, prospective trial will compare to historical controls from major ICD studies, specifically the percent of patients free from inappropriate shocks when implanted with Sorin’s PARADYM^TM and PARADYM RF³ families of dual-chamber ICDs and cardiac resynchronization therapy devices (CRT-D). The study will enroll up to 1,000 patients worldwide, including many U.S. sites.

Secondary objectives of this study include evaluating the percentage of shocks that are appropriately delivered over the one-year follow up, and assessing the incidence of unscheduled visits, reprogramming and medication change needs due to inappropriate shocks over that year.

"We are committed to patient-centric innovation, and our PARADYM and PARADYM RF defibrillators offer accurate, safe therapies, while preserving patients’ quality of life,” said Stefano Di Lullo, Sorin Group, President of the CRM Business Unit. "We are confident that the ISIS-ICD study will provide physicians valuable data on the efficacy of our PARAD+ algorithm.”

¹ Van Rees, Borleffs JW, De Bie MK et al. Inappropriate Implantable Cardioverter-Defi brillator Shocks: Incidence, Predictors, and Impact on Mortality. J Am Coll Cardiol 2011; 57:556-562

² Anselme F, Mletzko R, Bowes R et al. Prevention of inappropriate shocks in ICD recipients: a review of 10,000 tachycardia episodes. PACE 2007; 30:S128-S133. Study made using dual-chamber ICDs with standard dual-chamber arrhythmia classification algorithms.

³ Not available for distribution in the USA

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: 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