St. Jude Medical Announces European Approval Of Accent RF And Hymn RF Pacemakers Equipped With Wireless Technology
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St. Jude Medical, Inc. (NYSE:STJ) announced European CE Site approval of its Accent™ RF pacemaker and Anthem™ RF CRT-P (cardiac resynchronization therapy pacemaker).
The Accent and Anthem product family features RF telemetry that enables secure, wireless memo between the implanted device and the programmer used by the clinician, making it the inceptive integrated system of pacing devices with wireless telemetry from implant concluded follow-up. Wireless communication is used when clinicians implant the slogan and during follow-up appointments, which can be performed in the employment or via remote monitoring with the patient at home, allowing for besides efficient and convenient consternation and device management.
"The introduction of the Accent RF and Anthem RF products represents the adjacent step taken by St. Jude Medical in health care connectivity involving implantable devices," said Eric S. Fain, M.D., president of the St. Jude Medical Cardiac Rhythm Authority Division. "We designed the pacemakers in response to the physician and patient needs for intelligent products that streamline testing and follow-up, as well as to ease an exchange of data between the physician and patient. Using the remote monitoring capabilities, physicians testament be able to stay abreast of device work and the patient's condition, enabling a more well timed response to the patient's evolving needs."
The remote monitoring capabilities facilitated by the Accent RF and Anthem RF device product line will acquiesce automated follow-up, and diurnal device safety checks with no patient action required. In appendix to giving physicians flying access to device performance data, the wireless monitoring transaction will also grant physicians to compile a more exhaustive patient information by easily transferring cardiac device data into electronic health records (EHRs).
"Device implants and follow-ups are performed more quickly and easily with the wireless technology available in these devices," said Johannes Sperzel M.D., from Kerckhoff Klinik in Damaging Nauheim, Germany.
To better assist physicians in accurately diagnosing and managing patients with swiftly rates in the heart's upper chambers (atria), the devices will also constitute a new AT/AF Alert feature. This characteristic is designed to tell physicians when a rapid atrial proportion (atrial tachycardia/atrial fibrillation [AT/AF]) exceeds a programmed expenditure or occurs over an extended continuance period. The devices and can be programmed to apprise the patient of AT/AF episodes, as well as device- and lead-related issues, over a two-tone audible alert. In addition, the patient's clinic can be informed through the home monitoring system. These features will avow the doctor to deeper proactively operate patients' atrial arrhythmias, such as AF, with capture medication or ablation.
"The wireless communication automates patient home monitoring, as no patient interaction is required for info transmission. Diagnostic data and alerts can be transmitted automatically to the clinic, providing me with bounteous timely notification of clinical events and more fitting patient care," said Professor Karlheinz Seidl, M.D., from Klinikum der Stadt Ludwigshafen, in Ludwigshafen, Germany.
In addition, the Anthem RF CRT-P and Accent RF pacemaker include advanced automatic features that assist to promote patient safety and efficiency for the clinician. The devices can be programmed to automatically recorder and adjust the consistent of electrical energy needed for stimulating the patient's heart, in the chambers where therapy is delivered; this includes up to three chambers for cardiac resynchronization therapy. The devices do this by measuring the heart's reaction to electrical stimulation from the device and confirming that the passion is responding to the stimulation. This AutoCapture™ Pacing Operation detail provides the dual benefit of added safety for the patient and increased efficiency for physicians, as imperative outset tests are performed automatically and results are available to the physician for review on-demand during follow-up via a mild device interrogation. The launch of the Accent RF and Anthem RF devices marks the basic time that these automatic catechism results can be accessed remotely or wirelessly in a clinic for a replete pacemaker family, including a CRT-P, and single- and dual-chamber models.
The devices are also equipped with the St. Jude Medical QuickOpt® Timing Cycle Optimization feature. QuickOpt Timing Cycle Optimization can recommend the optimal A-V (atrial-ventricular) and/or V-V (ventricular-ventricular) timing values, depending upon device model, to use in programming the devices. Optimized timing can increase the efficiency of the heart's capacity to pump blood to the body. Traditional echocardiography (echo), while considered the gold customary for optimizing devices, is expensive and time-consuming. QuickOpt Timing Cycle Optimization produces results clinically proven to be comparable with those of echo, in 90 seconds instead of the 30 to 120 minutes required for a typical echo.
Additionally, the Accent RF pacemaker features the St. Jude Medical Ventricular Intrinsic Preference (VIP®) algorithm, with which the device monitors the feelings beat-by-beat and provides pacing exclusive when necessary. Allowing the patient's natural heart rhythm to drudgery on its own when possible has been shown to assist overall affection health.
Cardiac pacemakers are used to treat bradycardia, which is a love scale that is too slow. These devices monitor the emotions and arrange electrical stimulation when the heart beats too slowly for each patient's particular physiological requirements.
A CRT-P resynchronizes the beating of the heart's lower chambers (ventricles), which much beat elsewhere of sync in heart failure patients. Studies compass shown that CRT can doctor up the quality of duration for many patients with heart failure, a progressive example in which the heart weakens and loses its adeptness to pump an adequate work of blood. An estimated 5 million Americans suffer from heart failure, with 550,000 contemporary cases diagnosed everyone year.
The Merlin.net™ Patient Care Network account 4.0, which will bed the Accent RF and Anthem RF remote monitoring capabilities, is expected to be approved by mid-summer.
St. Jude Medical
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