MILAN--(BUSINESS WIRE)--Sorin Group (MIL:SRN), (Reuters Code: SORN.MI), a global medical company and a leader in the treatment of cardiovascular diseases, announced today CE mark approval and the European commercial launch of the REPLY ™ 200 family of pacemakers featuring Sleep Apnea Monitoring (SAM)2.
Sleep apnea is highly prevalent3 and vastly undiagnosed4 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-morbidities5,6.
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.7
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 device8). 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
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 80 countries.
For more information, please visit www.sorin.com
1 Refer to user’s manual furnished with the device for
complete instructions for use. SBD screening/SAM is NOT a formal
indication, instead, it is used as a reference point for further
diagnostics work by additional specialists.
2 REPLY 200 DR Implant manual, Sorin Group, Italy 2013.
3 Garrigues S, Pépin JL, Defaye P, et al. High prevalence of sleep apnea syndrome in patients with long-term pacing: the European Multicenter Polysomnographic Study. Circulation. 2007;115:1703-1709.
4 Lee W, Nagubadi S, Kryger MH, et al. Epidemiology of obstructive sleep apnea: a population-based perspective. Expert Rev Respir Med. 2008;2(3):349–364.
5 Gottlieb DJ, Yenokyan G, Newman AB, et al. Prospective study of obstructive sleep apnea and incident coronary heart disease and heart failure: the Sleep Heart Health Study. Circulation. 2010;122(4):352-360.
6 Mehra R, Benjamin EJ, Shahar E, et al. Association of nocturnal arrhythmias with sleep-disordered breathing: The Sleep Heart Health Study. Am J Respir Crit Care Med. 2006;173:910-916.
7 SORIN GROUP data on file 2013.
8 Reply 200 DR with typical conditions using SafeR: 50% A pacing, 5% V pacing, SAM ON, 60ppm, 2.5V, 0.35ms, 750 ohms, EGM & Diagnostics on, Rate response on, Sensors on. Reply 200 SR, 11.4 years of longevity in 7.5cc only with conditions: 100% V pacing, SAM ON, 60ppm, 2.5V, 0.35ms, 750 ohms, EGM & Diagnostics on, Rate response on, Sensors on.