Sorin Group, a global medical device company, has received CE mark approval for the REPLY 200 family of pacemakers, which feature sleep apnea monitoring for better management of cardiovascular co-morbidities.
The company has also launched REPLY 200 pacemakers in Europe.
Sleep apnea, which is a sleep disorder characterised by pauses in breathing, is considered to be highly prevalent and vastly undiagnosed in pacemaker patients.
It increases the risk of common cardiovascular co-morbidities like hypertension, atrial fibrillation and heart failure, and also complicates the management of common cardiovascular co-morbidities.
The REPLY 200 SR and DR pacemakers use a sensor that measures ventilation to automatically screen patients for the risk of severe sleep apnea.
The Respiratory Disturbance Index (RDI), calculated and reported by the pacemaker, has been validated against polysomnography, the gold standard method used to idenify sleep apnea, according to the company.
Using the REPLY 200 Sleep Apnea Monitoring feature, physicians can evaluate abnormal breathing events during the night using a six-month trend of the respiratory disturbance index (RDI), a severity threshold, and automatic alerts for severe sleep apnea patients.
Apart from sleep apnea monitoring, REPLY 200 DR pacemaker features an intelligent automatic algorithm called SafeR that provides patients with the benefits of physiologic pacing.
Sorin Group CRM business president Stefano Di Lullo said: "REPLY 200 with sleep apnea monitoring has the potential to significantly improve the management of bradycardia patients who are at risk for sleep breathing disorders and allows Sorin to further reinforce its innovation leadership in the low voltage CRM market and extend its market share."