Sorin’s Multi-Centre Sleep Apnea Monitoring/Pacemaker Study Starts Enrollment

In short

Sorin Group a leader in the treatment of cardiovascular diseases, announced today the first patient enrolment in the DREAM clinical trial. The primary objective of the study is to evaluate sensitivity and positive predictive value of Sleep Apnea Monitoring (SAM) in pacemaker patients, compared to polysomnography, the gold standard test to diagnose sleep apnea disorders.

Background

This European multi-centre, non-randomised, longitudinal study uses REPLY™ 2001, a new implantable pacemaker from Sorin Group, featuring SAM. This innovative feature is designed to screen and monitor Sleep Apnea Syndrome (SAS) in bradyarrhythmia patients implanted with a pacemaker, using sensors embedded in the implanted device

SAS, the most common sleep breathing disorder, is known to be associated with increased cardiovascular morbidity and mortality with the prevalence of SAS in patients suffering from bradyarrhythmia shown to be high.

Results from a 2007 study demonstrated that 3 out of 5 patients implanted with a pacemaker had some degree of SAS, and that 1 out of 5 suffered from severe SAS. Yet the vast majority of sleep apnea patients remain undiagnosed.

 

Clinician comments

According to the principal study investigator, Pascal Defaye, M.D. at University Hospital, Grenoble, France, “screening and monitoring sleep apnea in pacemaker patients makes sense. Sleep breathing disorders are common in patients implanted with pacemakers. Because sleep apnea increases the risk of hypertension and cardiovascular diseases, being able to screen and monitor this syndrome with a new pacemaker feature will, I believe, help improve our patients’ condition in the long run”.

Company comments

“Sorin Group is relentlessly dedicated to improving patient care” said Stefano Di Lullo, Sorin Group, President of the CRM Business Unit. “We are proud to initiate a study that aims to evaluate a new and advanced SAS feature that will help physicians better manage their patients’ cardiovascular 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, 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 p