Healthcare Industry News:  neuromodulation 

Devices Cardiology Regulatory

 News Release - May 11, 2009

St. Jude Medical Announces European Approval of Its Newest Heart Failure Devices Which Enable More Efficient Implantation and Follow-up

New products ensure necessary therapy delivery for heart failure patients

ST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ) today announced European CE Mark approval of its Promote 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 heart is responding, providing the dual benefit of added safety for the patient and added efficiency for physicians.

The Promote Accel CRT-D family of products also features the QuickFlex® µ (micro) left ventricular lead and CPS Aim® SL slittable inner catheter subselector designed to offer safer, more efficient implantation procedures and therapy delivery for patients with heart failure.

Because heart failure patients receive therapy in three of the heart’s four chambers—which helps to resynchronize the heart’s rhythm to more efficiently pump blood to the body—the Promote Accel CRT-D features automatic confirmation of capture in all three of these chambers. This ensures that heart failure patients receive the therapy they need to lessen symptoms and help slow the progression of the disease. The Promote Accel CRT-D also includes biventricular triggered pacing in which a sensed heart beat triggers pacing in both of the lower chambers, facilitating resynchronization. This is particularly useful when arrhythmias of the upper chambers of the heart (atrial fibrillation) are present.

To better assist physicians in accurately diagnosing and managing patients with high heart rates in the heart’s upper chambers (atria), the Promote Accel CRT-D also include a new AT/AF Alert feature. AT/AF Alerts are designed to notify physicians when a high atrial rate (atrial tachycardia/atrial fibrillation [AT/AF]) exceeds a programmed value or when it is accompanied by a high rate in the heart’s lower chambers. The device can be programmed to notify the patient through a unique vibratory alert which has been proven more effective than audible alerts.1 Additionally, the device has the ability to inform the patient’s clinic through 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 assist physicians as they address their patients’ unique medical conditions and therapy needs,” said Eric S. Fain, M.D., president of the St. Jude Medical Cardiac Rhythm Management Division. “This new system—consisting of the device, the new QuickFlex µ lead and the CPS Aim SL inner catheter—is intended to provide optimal care from implant through follow-up.”

The QuickFlex µ lead, used in cardiac resynchronization therapy, has an ultra-thin 4.3 French next-generation lead body, designed to enable physicians to implant the lead in the heart’s lower left chamber (left ventricle, or LV). Because delivering the LV lead to the desired target vessel can be challenging, especially when the target vessel is small or tortuous, the QuickFlex µ lead helps to improve access to these vessels.

The QuickFlex µ lead features Optim® lead insulation, a hybrid insulation material unique to St. Jude Medical and created specifically for cardiac leads. Optim lead insulation blends the biostability and flexibility of high-performance silicone rubber with the strength, tear resistance and abrasion resistance of polyurethane and is designed to provide increased durability, along with the flexibility and handling characteristics that facilitate device implantation.

The lead has short tip and ring electrodes (used to conduct energy), reducing the length of the lead's rigid portions. This, in addition to the lead’s steerable tip, helps to facilitate delivery through 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 µ lead also features an S-shaped curve, which is standard on the QuickFlex lead models. This design feature helps to provide 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® lead clinical study and demonstrated a high implant success rate and low dislodgement rate.

The CPS Aim SL inner catheter subselector is the latest addition to a comprehensive and complementary set of leads and tools from St. Jude Medical designed to decrease implant times and increase control over LV access, delivery and fixation. The CPS Aim SL inner catheter subselector provides a new capability to directly deliver leads that are thinner than 5.1 French, such as the QuickFlex µ lead, to the left side of the heart. The second-generation catheter subselector is specifically designed to allow efficient lead placement to vessels that may have been previously unreachable. Three curve shapes and superb fluoroscopic visibility ease implantation and give physicians access to their first-choice locations, even in cases of difficult angulations and tortuous anatomies. The low slit force provides for easy removal after lead 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 - program a device's timing cycles to help deliver optimal therapy to patients. As demonstrated in clinical studies, the QuickOpt optimization feature produces results that are comparable to echocardiography, the current gold standard, but is significantly less costly and time-consuming.
  • DeFT Response® technology - which is designed to help devices meet the needs of patients who may have high or varying thresholds for the amount of energy required to defibrillate the heart in the event of a life-threatening arrhythmia.
  • SenseAbility® technology - which is designed to optimize sensing to help 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 often beat out of sync in heart failure patients. Studies have shown that CRT can improve the quality of life for many patients with heart failure, a progressive condition in which the heart weakens and loses its ability to pump an adequate supply of blood. About 5 million Americans suffer from heart failure, with 550,000 new cases diagnosed every year, according to the American Heart Association.

About St. Jude Medical

St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. Headquartered in St. Paul, Minn., St. Jude Medical employs approximately 14,000 people worldwide and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit www.sjm.com.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the Company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company’s control and the risk factors and other cautionary statements described in the Company’s filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the Company’s Annual Report on Form 10-K for the fiscal year ended January 3, 2009. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

1 Bennett MT et al. The ICD patient alert is potentially an unreliable ICD warning feature. Presented at the Canadian Cardiovascular Congress, Toronto, Ontario, October 26, 2008.


Source: St. Jude Medical

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