St. Jude Medical Announces European Approval Of Its Newest Heart Failure Devices Which Enable Aggrandized Efficient Implantation And Follow-up
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St. Jude Medical, Inc. (NYSE:STJ) announced European CE Mark approval of its Bolster Accel™ implantable cardiac resynchronization therapy defibrillator (CRT-D). The Promote Accel CRT-D automatically tailors treatment to individual patient needs by measuring the heart's reaction to therapy and ensuring that the passion is responding, providing the dual aid of added safety for the patient and added efficiency for physicians.
The Promote Accel CRT-D family of products also features the QuickFlex® Î (micro) left ventricular guidance and CPS Aim® SL slittable inner catheter subselector designed to offer safer, more efficient implantation procedures and therapy delivery for patients with affection failure.
Whereas feelings failure patients receive therapy in three of the heart's four chambers-which helps to resynchronize the heart's rhythm to augmented efficiently pump blood to the body-the Champion Accel CRT-D features automatic confirmation of receive in all three of these chambers. This ensures that heart failure patients receive the therapy they itch to lessen symptoms and help slow the succession of the disease. The Boost Accel CRT-D very includes biventricular triggered pacing in which a sensed heart beat triggers pacing in both of the lower chambers, facilitating resynchronization. This is exclusively useful when arrhythmias of the upper chambers of the love (atrial fibrillation) are present.
To better facilitate physicians in accurately diagnosing and managing patients with flying heart rates in the heart's upper chambers (atria), the Promote Accel CRT-D too comprehend a dewy AT/AF Alert feature. AT/AF Alerts are designed to alert physicians when a high atrial scale (atrial tachycardia/atrial fibrillation [AT/AF]) exceeds a programmed appraisal or when it is accompanied by a formidable ratio in the heart's lower chambers. The device can be programmed to tell the patient a unique vibratory alert which has been proven more effective than audible alerts.1 Additionally, the device has the competence to inform the patient's clinic ended the St. Jude Medical Merlin@home® transmitter and Merlin.net™ Patient Care Network (PCN).
"The Promote Accel CRT-D is the latest product offering from St. Jude Medical designed to helping hand physicians as they address their patients' only medical conditions and therapy needs," said Eric S. Fain, M.D., head of the state of the St. Jude Medical Cardiac Rhythm Management Division. "This cutting edge system-consisting of the device, the modern QuickFlex Î lead and the CPS Stop SL inner catheter-is intended to care optimal care from implant down follow-up."
The QuickFlex Î lead, used in cardiac resynchronization therapy, has an ultra-thin 4.3 French next-generation lead body, designed to enable physicians to implant the direction in the heart's lower left hospital ward (left ventricle, or LV). Because delivering the LV lead to the desired argument vessel can be challenging, expressly when the intent vessel is small or tortuous, the QuickFlex Î cutting edge helps to develop access to these vessels.
The QuickFlex Î head features Optim® escort insulation, a hybrid insulation material unique to St. Jude Medical and created specifically for cardiac leads. Optim bob insulation blends the biostability and flexibility of high-performance silicone rubber with the strength, tear resistence and abrasion resistance of polyurethane and is designed to provide increased durability, along with the flexibility and handling characteristics that ease device implantation.
The margin has short gratuity and ring electrodes (used to conduct energy), reducing the length of the lead's arduous portions. This, in addition to the lead's steerable tip, helps to help delivery terminated the acute bends that characterize the vessels in the left side of the heart, enabling physicians to better maneuver the lead to the optimal position for therapy.
The QuickFlex Â prompt and features an S-shaped curve, which is customary on the QuickFlex example models. This example quality helps to feed stability once the lead is placed in the desired vein inside the heart. The S-shaped curve was evaluated in the company's 1056T QuickSite® facade clinical interpret and demonstrated a high implant attainment rate and low dislodgement rate.
The CPS Aim SL inner catheter subselector is the advanced appendix to a comprehensive and supplementary fix of leads and tools from St. Jude Medical designed to decrease implant times and accretion polity over LV access, delivery and fixation. The CPS Site SL inner catheter subselector provides a new capability to directly deliver leads that are thinner than 5.1 French, such as the QuickFlex Î lead, to the left side of the heart. The second-generation catheter subselector is specifically designed to own efficient vanguard placement to vessels that may corner been formerly unreachable. Three curve shapes and superb fluoroscopic visibility cooperate implantation and give physicians access to their first-choice locations, even in cases of difficult angulations and tortuous anatomies. The low slit energy provides for manageable removal after heavy placement.
The Promote Accel CRT-D includes other therapy-enhancing St. Jude Medical features, such as:
- QuickOpt® Timing Cycle Optimization - A programmer-based optimization method for people with CRT-Ds and implantable cardioverter defibrillators (ICDs) that helps physicians quickly - in 90 seconds - programme a device's timing cycles to help deliver optimal therapy to patients. As demonstrated in clinical studies, the QuickOpt optimization attribute produces results that are comparable to echocardiography, the in fashion gold standard, nevertheless is significantly less costly and time-consuming.
- DeFT Response® technology - which is designed to cure devices meet the needs of patients who may annex high or varying thresholds for the proportions of coercion required to defibrillate the emotions in the appearance of a life-threatening arrhythmia.
- SenseAbility® technology - which is designed to optimize sensing to aid protect against inappropriate shocks.
Cardiac resynchronization therapy - delivered in an ICD or a pacemaker - resynchronizes the beating of the heart's lower chambers (ventricles), which much beat out of sync in heart failure patients. Studies have shown that CRT can come around the genius of heart for innumerable patients with heart failure, a progressive condition in which the heart weakens and loses its ability to pump an full service of blood. Approximately 5 million Americans suffer from heart failure, with 550,000 new cases diagnosed every year, according to the American Heart Association.
St. Jude Medical
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