Berlin January 8, 2008. BIOTRONIK GmbH & Co. KG announces the CE approval and first worldwide implantation of the Cylos 990 family of cardiac pacing devices. The Cylos 990 family offers the widest range of advanced bradycardia therapy options, as well as BIOTRONIK Home Monitoring® designed to optimize hemodynamics of a patients’ circulatory system and streamline the follow-up of patients by the physician.
The Cylos 990 family is unique among the competition in its pioneering technology known as Closed Loop Stimulation (CLS). The CLS concept offers distinct clinical advantages over other rate-adaptive device algorithms because of its ability to restore a more natural physiologic heart rate therapy relative to the metabolic needs of the individual patient. CLS functions within the natural cardiovascular control-loop, allowing it to mimic the sinus node, the natural, biologic pacemaker of the human heart. Furthermore, CLS initiates pacing earlier and more effectively during periods of emotional or mental stress, providing better heart rate response and variability, which together improve hemodynamics, by imitating the ability of the sinus node to modulate cardiac output.
Advanced Therapy Options for Streamlined Follow-Up
In response to the large and growing number of implanted devices, technologies which ease complex programming and enable simplified patient follow-up become increasingly important. The Cylos 990 family leads the industry with the improved programmability and streamlined follow-up capability. Some of these new features include AV-AdVisor®, ProgramConsult® and Automatic Atrial Threshold Testing.
The Cylos 990 is the first device to offer two complementary algorithms which effectively reduce ventricular pacing while maintaining optimal hemodynamics. Due to its impact on HF hospitalization and mortality, avoidance of unnecessary ventricular pacing is a mandatory topic. The AV-AdVisor® provides the clinician with an intelligent and informed suggestion for optimizing AV settings on a patient-by-patient basis using accumulated feedback from device event counters and intrinsic diagnostic data. AV-AdVisor® reduces the complexity that is found in analysing the patients’ optimal AV delay. In combination with the IRS plus algorithm, AV-AdVisor® represents an optimal tool for collecting AV timing data. This data will be used for automatic programming of individual AV timing solutions, resulting in a significant reduction of right ventricular pacing.
Another technical advancement in the Cylos 990 is ProgramConsult®, which allows the caregiver to perform a complete device programming and set-up with just the click of one button. This new advanced feature reflects current “best practice” programming suggestions from a panel of industry and clinical experts with significant real-world experience using pacemakers. Their thoughtful selection of “best practice” criteria come from a wide-range of frequent pacemaker indications. Together with TrendView®, a feature that gives an overview of accumulated important therapeutic trends for easy diagnostics on one programming screen, Cylos 990 will not only make follow-ups easier but reduce the amount of time needed.
Prof. Richard Sutton, Professor of Clinical Cardiology from St Mary’s Hospital, London (UK), implanted the first world-wide Cylos 990 pacemaker today and commented on the new therapy options available in the Cylos 990: “With the inclusion of the new features in the Cylos 990 such as the AV-AdVisor®, and ProgramConsult®, BIOTRONIK has created an expert system. Such systems are extremely effective at reducing complicated device programming and speeding follow-ups”
Simultaneously Dr. Martinez Ferrer, president of the cardiac pacing section of the Spanish Society of Cardiology, from Txagorritxu Hospital, Vitoria (ES), successfully implanted the new Cylos 990 pacemaker and stated: “Having more automaticity in the pacemakers, like the features available in the Cylos 990 with Closed Loop Stimulation, makes the complicated programming of sensors, for example, obsolete. This allows physicians more time to spend on the clinical aspects of the patients”.
The Cylos 990 offers a level of automaticity not previously seen in the competitive devices with the inclusion of two algorithms engineered to perform fully automatic atrial and ventricular threshold tests. This leap forward in technology means that clinicians are able to select from either automatic or manual measurement of thresholds with the click of just one button, while maintaining the highest level of reliability and patient safety.
Following the first worldwide implantation of the Cylos 990 pacemaker, BIOTRONIK will also commence with the Cylos 990 MASTER Study which more broadly evaluates the effectiveness of these new advanced therapy options. This has started with the first implant of the Cylos 990 by Dr. Ludwig Binner from the University Hospital in Ulm (GER) and is expected to run for a period of three months.
CYLOS 990 – featuring Advanced Patient Management
"Using a unique fully automatic physiological sensor (Closed Loop Stimulation) in combination with novel advanced follow up solutions, BIOTRONIK has set an important new standard in device technology, allowing physicians to concentrate more on patient health issues instead of the complexities of device programming”, commented Marlou Janssen, Vice President Marketing and Sales CRM, BIOTRONIK. “In conjunction with the BIOTRONIK Home Monitoring® system of automatic, fully-mobile remote data transmission, the Cylos 990 offers the unique possibility of early detection, the prevention of complications and an improvement in the well-being of the patient."
About BIOTRONIK GmbH & Co. KG
As one of the worlds leading cardiovascular medical device companies, with several million implanted devices, BIOTRONIK is present in all world markets. Known for having its finger on the pulse of the medical community, BIOTRONIK helps to assess the challenges physicians face, and provides the best solutions, be they cardiac implants, minimal invasive devices or other products and services ranging from diagnosis to electrotherapy and vascular intervention or therapy management. Quality, innovation, and reliability define BIOTRONIK and its growing success, and deliver confidence and peace of mind to physicians and their patients worldwide.