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SJM Gets FDA OK for New AICDs

May 11th, 2009 Medgadget Editors Cardiac Surgery, Radiology


St. Jude Medical is reporting that it has received FDA approval for two of the company’s latest cardiac defibrillators, the Promote Plus cardiac resynchronization therapy defibrillator and Current Plus implantable cardioverter defibrillator. Both models have wireless reporting capabilities and SJM says they should prove to be more comfortable for the patients.
From the press release:

To better assist physicians in accurately diagnosing and managing patients with fast rates in the heart’s upper chambers (atria), the Promote Plus CRT-D and Current Plus ICDs also include a new atrial tachycardia/atrial fibrillation (AT/AF) Alert feature. This feature is designed to notify physicians when a rapid atrial rate exceeds a programmed value and occurs over an extended time period. These devices can also be programmed to notify the patient through a unique vibratory alert that has been clinically proven more effective than audible alerts.1 Additionally, the devices have the ability to inform the patient’s clinic through the St. Jude Medical Merlin@home® transmitter and Merlin.net™ Patient Care Network (PCN). These features allow the physician to better manage patients’ atrial arrhythmias, such as AF.
The Promote Plus CRT-D and Current Plus ICDs are built on the St. Jude Medical consolidated hardware and software “Unity” device platform and include the company’s advanced safety features and algorithms for better patient management. These include improved lead monitoring capabilities – including daily checks of all pacing and shock configurations – that provide added patient safety.
TailoredTherapy features in these devices include:
* QuickOpt® timing cycle optimization – a programmer-based optimization method that is proprietary to St. Jude Medical that is used with CRT-Ds, CRT-Ps (cardiac resynchronization therapy pacemakers) and ICDs to help physicians quickly program the device’s timing cycles – in about 90 seconds – to help deliver optimal therapy to patients
* DeFT Response® technology – designed to help devices meet the needs of patients with high or varying defibrillation thresholds, helping physicians to ensure appropriate delivery of life-saving therapy
* VIP® (Ventricular Intrinsic Preference) algorithm – provides a delay in device stimulation of the lower chambers of the heart (ventricles) to allow the patient’s own heart rhythm to prevail when possible. The VIP technology is designed to provide device stimulation only when needed, which has been shown to be better for patients’ overall heart health.
* SenseAbility® technology – designed to enable physicians to program the device to more accurately sense abnormal heart rhythms, thereby protecting the patient from receiving inappropriate shocks

Press release: St. Jude Medical Announces FDA Approval of Current Plus ICD and Promote Plus CRT-D Devices to Provide Therapy for Life-Threatening Arrhythmias and Heart Failure

Medgadget Editors

Medical technologies transform the world! Join us and see the progress in real time. At Medgadget, we report the latest technology news, interview leaders in the field, and file dispatches from medical events around the world since 2004.

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