Sorin announced today CE mark approval and the European commercial launch of the REPLY ™ 200 family of pacemakers featuring Sleep Apnea Monitoring (SAM). According to the press release:
Sleep apnea is highly prevalent and vastly undiagnosed in pacemaker patients. It increases the mortality risk and the risk of common cardiovascular co-morbidities such as hypertension, atrial fibrillation (AF) and heart failure (HF). Moreover, sleep apnea complicates the management of common cardiovascular co-morbidities.
The REPLY 200 SR and DR pacemakers automatically screen patients for the risk of severe sleep apnea using a highly reliable sensor that measures ventilation. The Respiratory Disturbance Index (RDI), calculated and reported by the pacemaker, has been validated against polysomnography, the gold standard method used to diagnose sleep apnea.
With the REPLY 200 Sleep Apnea Monitoring feature, physicians have the ability to assess abnormal breathing events during the night using a 6-month trend of the RDI, a severity threshold, and automatic alerts for severe sleep apnea patients.
“The REPLY 200 provides us with an intuitive tool to offer more comprehensive care to our patients. Many of our pacemaker patients have co-morbidities such as hypertension and AF. If cardiovascular medical treatment is not working as well as expected for the patient, we can easily check whether sleep apnea is a complicating factor and adjust the treatment plan accordingly,” said Dr. Ezio Aimè, IRCCS Policlinico, San Donato, Milan, Italy.
The REPLY 200 pacemakers are the world’s smallest pacemakers with best-in-class longevity vs. size (12 years longevity in 8 cc device). In addition to Sleep Apnea Monitoring, REPLY 200 DR pacemaker features SafeR™, an intelligent automatic algorithm that provides patients with the benefits of physiologic pacing.
“There is a real unmet need for cardiovascular patients to be screened as early as possible,” commented Professor Hendrik Bonnemeier, University Hospital Schleswig-Holstein Campus Kiel, Germany, after his first implantation of the REPLY 200. “However, polysomnography, the gold standard for sleep apnea monitoring, is too costly and time consuming for hospitals to render widespread screening. REPLY 200 can pre-screen and pre-select pacemaker patients with severe sleep apnea so that they can be treated efficiently.”
“Sorin Group is dedicated to extending the boundaries of cardiovascular disease management and improving patient care,” said Stefano Di Lullo, President of the CRM Business. “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.”
Among the first implanters were:
Professor H. Bonnemeier, University Hospital Schleswig-Holstein Campus Kiel, Germany
Dr. V. Leonhardt, Herzschrittmacher- & ICD-Zentrum, Berlin, Germany
Dr. H. Hazeleger, Viecuri Medical Center, Venlo, The Netherlands
Dr. E. Aimè, IRCCS Policlinico, San Donato, Milan, Italy