ANSWER Study Shows That SafeR(TM) Safely Reduces Right Ventricular Pacing in Pacemaker Patients and Subsequently Improves Clinical Outcomes

Results from SORIN GROUP’s long-term clinical randomized trial showed that the SafeR pacing mode significantly reduces heart failure events (death and hospitalization) NICE, France--(BUSINESS WIRE)--Sorin Group, a global medical company and a leader in the treatment of cardiovascular diseases, announced the results of the ANSWER clinical study. The trial results were presented at CARDIOSTIM 2014 Annual Scientific Sessions, in Nice, France, by Dr. Martin Stockburger, Charité University Hospital Berlin, Germany. Previous studies have shown that unnecessary right ventricular pacing (Vp) has a detrimental effect on the hemodynamic function of the pacemaker patient’s heart. The ANSWER study evaluated whether the minimization of Vp using the SafeR algorithm improves clinical outcomes for dual chamber pacemaker (PM) patients implanted for sinus node disease (SND) or for atrio-ventricular block (AVB). The percentage of Vp at one-year follow-up, the first primary endpoint, was significantly reduced in SafeR mode compared to a standard dual chamber pacing (DDD) mode (4.8% vs. 95.4%, pAbout the ANSWER study ANSWER is a multicenter, international controlled randomized trial with three-year follow-up that involved 44 European centers in seven countries. One month after enrollment, patients (n=650) were randomized to either the SafeR mode (n=314) or the DDD mode (n=318) (i.e., without minimized ventricular pacing) over a three-year period. The following results were released: • SafeR significantly reduced Vp compared with the DDD mode (11.5% vs. 93.6%, pAbout SafeR pacing mode The SafeR algorithm was developed to manage sinus node dysfunction as well as all types of atrio-ventricular blocks (types I, II and III) and eliminate unnecessary ventricular pacing (Vp) at rest and exercise by combining the benefits of AAI and DDD pacing.¹ This signature feature is present in all Sorin pacemakers and ICDs, including the latest generation of KORA 100 MRI conditional pacemakers that focus on the proactive management of co-morbidities. 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, the Company focuses on two major therapeutic areas: Cardiac Surgery (cardiopulmonary products for open heart surgery and heart valve repair or replacement products) and Cardiac Rhythm Management (pacemakers, defibrillators and non invasive monitoring to diagnose 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 1. Davy JM, et al. Pacing Clin Electrophysiol. 2012;35(4):392-402.